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Clinical trials
catalyst calendar across sponsors →Studies where 4503.T is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
Of the 500 shown: 462 interventional · 38 observational · 57 with posted results
Held by 0 tracked-famous managers · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a StrokeNCT07318714Number of participants with Dose-Limiting Toxicity (DLT)Randomized · Double-masked · Treatment | Phase 1/2 | Recruiting | Drug: ASP2246 · Procedure: Brain surgery, Sham surgery · Other: Rehabilitation therapy | Chronic Ischemic Stroke | 84 | 2030-02-28 | in 1,289 d | 2026-07-09 |
| A Study of ASP3082 in Adults With Advanced Solid TumorsNCT05382559Incidence of Dose Limiting Toxicities (DLTs)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: Setidegrasib, Cetuximab, Leucovorin, Oxaliplatin, Fluorouracil, Irinotecan, Nanoparticle albumin-bound-paclitaxel, Gemcitabine, Docetaxel, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Liposomal Irinotecan | Solid Tumor | 681 | 2028-12-31 | in 865 d | 2026-07-31 |
| A Study to Find a Suitable Dose of ASP5834 in Adults With Solid TumorsNCT07094204Incidence of Dose Limiting Toxicities (DLTs) (Dose Escalation only)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: ASP5834, panitumumab | Solid Tumor, Non-Small-Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer | 364 | 2028-11-30 | in 834 d | 2026-05-18 |
| A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular DegenerationNCT06970665Number of participants with Treatment Emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 4 | Active, not recruiting | Drug: avacincaptad pegol | Geographic Atrophy, Age-Related Macular Degeneration | 17 | 2027-06-30 | in 315 d | 2026-08-12 |
| A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) MutationNCT03182244results2025-01-14Overall Survival (OS)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Active, not recruiting | Drug: Gilteritinib, Cytarabine, Mitoxantrone, Etoposide, G-CSF, Fludarabine | AML With FLT3 Mutation | 276 | 2023-12-25actual | — | 2026-07-16 |
| A Study to Find a Suitable Dose of ASP4396 in Adults With Solid TumorsNCT06364696Incidence of Dose Limiting Toxicities (DLTs) for ASP4369Non-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Company's strategic decision | Drug: ASP4396 | Solid Tumor | 60 | 2026-06-17actual | — | 2026-07-16 |
| Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid ArthritisNCT03971253observationalSafety assessed by frequency of adverse events (AEs) | — | Completed | Drug: Peficitinib | Rheumatoid Arthritis (RA) | 3,000 | 2026-05-29actual | — | 2026-06-10 |
| A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through MenopauseNCT06206421Number of participants with Adverse Events (AEs)Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Fezolinetant, Placebo | Hot Flashes | 277 | 2026-03-19actual | — | 2026-04-08 |
| A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through MenopauseNCT06206408Mean change from baseline in the frequency of mild to severe vasomotor symptoms (VMS)Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Fezolinetant, Placebo | Hot Flashes | 410 | 2025-10-22actual | — | 2025-12-23 |
| Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal AnemiaNCT04408820observationalProportion of participants with Adverse Drug Reactions (ADR) | — | Completed | Drug: Roxadustat | Renal Anemia | 2,104 | 2025-06-23actual | — | 2025-07-25 |
| A Study to Evaluate ASP0367 in Participants With Primary Mitochondrial MyopathyNCT04641962results2025-06-17Change From Baseline in Distanced Walked During a 6 Minute Walk Test (6MWT).Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Due to failure to meet the pre-specified criteria for efficacy | Drug: Bocidelpar, Placebo | Primary Mitochondrial Myopathy | 34 | 2024-05-08actual | — | 2025-07-03 |
| A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based ChemotherapyNCT03641560results2025-01-23Number of Participants With Treatment- Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Enzalutamide, Androgen deprivation therapy (ADT) | Metastatic Castration Resistant Prostate Cancer | 52 | 2024-02-20actual | — | 2026-06-24 |
| A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through MenopauseNCT05034042Mean change from baseline in the frequency of mild, moderate and severe vasomotor symptom (VMS)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Fezolinetant, Placebo | Hot Flashes | 147 | 2022-11-11actual | — | 2024-10-26 |
| A Study to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Participants With Duchenne Muscular Dystrophy (DMD)NCT04184882Number of participants with Treatment Emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: Operational Reasons | Drug: Bocidelpar, Placebo | Duchenne Muscular Dystrophy (DMD) | 8 | 2022-09-04actual | — | 2024-10-22 |
| A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During SurgeryNCT05457842results2024-05-01Optimal Dose of ASP5354 for Lymph Node (LN) VisualizationOpen-label · DiagnosticStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Company's strategic decision | Drug: pudexacianinium chloride | Sentinel Lymph Node Biopsy, Breast Cancer, Melanoma | 1 | 2022-09-02actual | — | 2024-11-20 |
| Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid TumorsNCT04094506Number of participants with Dose Limiting Toxicity (DLT) for Dose level 1200 mg and 2000 mgNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ASP1948 | Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies | 9 | 2022-02-02actual | — | 2024-11-01 |
| Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)NCT03471728observationalIncidence of diarrhea | — | Completed | Drug: linaclotide | Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases), Irritable Bowel Syndrome With Constipation (IBS-C) | 2,475 | 2021-12-31actual | — | 2024-10-18 |
| A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal SurgeryNCT04238481results2023-02-13Percentage of Participants With Successful Anatomical Visualization of the Index Ureter(s)Randomized · Open-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Pudexacianinium chloride | Laparoscopic/Minimally Invasive Colorectal Surgery | 13 | 2021-11-18actual | — | 2024-10-24 |
| A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.NCT02310321results2024-10-16Phase 1 Part: Maximum Tolerated Dose (MTD) of GilteritinibNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: Gilteritinib, Idarubicin, Cytarabine | Acute Myeloid Leukemia, FLT3-mutated Acute Myeloid Leukemia | 97 | 2021-08-25actual | — | 2025-09-02 |
| Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury (AKI) Following Coronary Artery Bypass Graft (CABG) and/or Valve SurgeryNCT03941483results2022-10-04Percentage of Participants Developing AKI Based on Serum Creatinine (SCr) Criteria Within 72 Hrs From End of Surgery (AKI-SCr72h)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ASP1128, Placebo | Acute Kidney Injury (AKI) | 351 | 2021-07-26actual | — | 2024-12-04 |
| Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASP5354 in Healthy Adult Japanese Male ParticipantsNCT04878471Number of participants with Adverse Events (AEs)Randomized · Double-masked · Basic science | Phase 1 | Completed | Drug: Pudexacianinium chloride, Placebo | Healthy Volunteers | 12 | 2021-07-22actual | — | 2024-10-16 |
| A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder CancerNCT03219333results2021-12-17Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Enfortumab vedotin | Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms, Renal Pelvis Neoplasms, Urothelial Cancer, Ureteral Neoplasms, Urethral Neoplasms | 219 | 2020-10-27actual | — | 2024-08-27 |
| Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid TumorsNCT03945253Safety and tolerability assessed by Dose Limiting Toxicity (DLT)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ASP8374 | Advanced Solid Tumors | 6 | 2020-06-12actual | — | 2024-11-13 |
| A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) AdenocarcinomaNCT03528629Dose Limiting Toxicities (DLT) in Safety PartNon-randomized · Open-label · Treatment | Not applicable | Completed | Drug: Zolbetuximab | Gastric Cancer, Gastro-esophageal Junction (GEJ) Cancer | 18 | 2020-06-09actual | — | 2024-12-02 |
| A Study to Assess Effect of Exercise Program Provided by Smartphone Application on the Body CompositionNCT04194697Change from baseline in visceral fat areaRandomized · Open-label · Other | Not applicable | Completed | Behavioral: Exercise, No exercise | Healthy Volunteers | 100 | 2020-06-08actual | — | 2024-11-05 |
| Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate CancerNCT02918968results2021-05-21Time to PSA Progression With 1st Line AAT (TTPP1)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Enzalutamide, Flutamide · Other: Androgen deprivation therapy | Prostate Cancer | 206 | 2020-03-27actual | — | 2024-12-09 |
| A Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar DisorderNCT03403790observationalSafety assessed by incidence of serious adverse events | — | Completed | Drug: Quetiapine | Depression, Bipolar Disorder | 369 | 2020-03-19actual | — | 2024-10-16 |
| A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use SituationsNCT01410747observationalIncidence of renal events (renal failure and progression to dialysis) | — | Completed | Drug: Tacrolimus | Lupus Nephritis | 1,484 | 2020-01-31actual | — | 2024-10-22 |
| Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal DialysisNCT01903213observationalSafety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests | — | Completed | Drug: bixalomer | Chronic Renal Failure | 123 | 2019-12-31actual | — | 2024-10-22 |
| A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial PneumoniaNCT02159651observationalOverall survival | — | Completed | Drug: tacrolimus | Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis | 179 | 2019-12-23actual | — | 2024-10-22 |
| Development of Visual Function Evaluation MethodNCT03281005observationalSlit-lamp microscopy in Part 1A and 2 | — | Completed | — | Retinitis Pigmentosa | 18 | 2019-11-21actual | — | 2024-10-21 |
| A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015KNCT01638013results2020-10-23Number of Participants With Adverse EventsNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Peficitinib | Arthritis, Rheumatoid | 843 | 2019-09-30actual | — | 2024-10-28 |
| A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With AnemiaNCT02988973Change from baseline in the average Hemoglobin (Hb)Randomized · Open-label · Treatment | Phase 3 | Completed | Drug: roxadustat, DA | Chronic Kidney Disease | 334 | 2019-09-13actual | — | 2024-10-31 |
| Development of Visual Function Evaluation Method (2)NCT03626207observationalSlit-lamp-microscopy | — | Completed | — | Retinitis Pigmentosa | 8 | 2019-06-26actual | — | 2024-10-21 |
| Specified Drug Use-Results Survey of RegniteNCT01887613observationalSafety such as occurrence of adverse drug reactions and lab-tests | — | Completed | Drug: Regnite | Restless Legs Syndrome | 1,597 | 2019-02-28actual | — | 2019-04-29 |
| A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial CarcinomaNCT03070990Safety assessed by incidence of adverse eventsRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Enfortumab vedotin | Metastatic Urothelial Cancer | 19 | 2019-02-25actual | — | 2024-10-18 |
| Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney DiseaseNCT02805348observationalChange from baseline in the serum concentrations of phosphate | — | Completed | Drug: Bixalomer | Chronic Kidney Disease | 144 | 2018-12-31actual | — | 2024-10-16 |
| Long-Term Specified Drug Use-Results Survey for Xtandi CapsuleNCT02669771observationalIncidences of Adverse Events | — | Completed | Drug: enzalutamide | Castration-resistant Prostate Cancer | 1,018 | 2018-11-30actual | — | 2024-11-21 |
| Specified Drug Use Results Survey of Ipragliflozin Treatment in type2 Diabetes PatientsNCT02479399observationalIncidence of cardiovascular adverse events | — | Completed | Drug: ipragliflozin | Type 2 Diabetes | 11,412 | 2018-10-16actual | — | 2024-10-22 |
| A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on MethotrexateNCT03257852ACR50 response rateRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ASP5094, Placebo · Other: Methotrexate therapy | Rheumatoid Arthritis (RA) | 66 | 2018-09-19actual | — | 2024-10-31 |
| A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With AnemiaNCT02964936Change from baseline in hemoglobin (Hb) response rateRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: roxadustat | Chronic Kidney Disease | 100 | 2018-08-15actual | — | 2024-10-31 |
| A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome PatientsNCT03053427results2019-07-10Change From Baseline in International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Placebo, Gabapentin enacarbil | Restless Legs Syndrome (RLS) | 375 | 2018-06-25actual | — | 2024-12-12 |
| A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female SubjectsNCT03436849Safety assessed by incidence of adverse events (AEs) in Part 1Randomized · Triple-masked · Basic science | Phase 1 | Completed | Drug: ESN364, Placebo | Healthy Subjects | 44 | 2018-05-23actual | — | 2024-10-16 |
| ASP8302 Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese SubjectsNCT03361540Safety assessed by incidence of adverse events (AEs)Randomized · Triple-masked · Basic science | Phase 1 | Completed | Drug: ASP8302, Placebo | Healthy Subjects | 56 | 2018-04-30actual | — | 2024-10-21 |
| Special Drug Use Surveillance of Irribow in Female PatientsNCT02612649observationalIncidences of Adverse Drug Reactions | — | Completed | Drug: Ramosetron | Diarrhea-predominant Irritable Bowel Syndrome | 793 | 2018-03-31actual | — | 2024-10-21 |
| A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With AnemiaNCT02952092Change from baseline in the average hemoglobin (Hb)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: roxadustat, Darbepoetin alfa | Hemodialysis Chronic Kidney Disease Patients With Anemia | 303 | 2018-03-13actual | — | 2024-10-30 |
| A Dose-finding Study of ASP4070NCT03101267results2020-06-30Change From Pre-Exposure in Mean Total 3 Nasal Symptom Score (3TNSS) 120 to 180 Minutes After Start of Cedar Pollen Exposure on Day 183Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ASP4070, Placebo | Rhinitis, Allergic, Seasonal | 150 | 2018-01-26actual | — | 2024-11-26 |
| Specified Drug Use-results Survey of Betanis TabletsNCT01898624observationalThe occurrence of ocular adverse events such as increased intraocular pressure and worsening of glaucoma | — | Completed | Drug: mirabegron | Overactive Bladder | 300 | 2018-01-10actual | — | 2018-02-05 |
| A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidney Disease Patients With AnemiaNCT02780141Hemoglobin (Hb) Response rateRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: roxadustat | ESA-naive Hemodialysis Chronic Kidney Disease Patients With Anemia | 75 | 2017-12-12actual | — | 2024-10-30 |
| Study of Ipragliflozin in Patients With Type 2 Diabetes Mellitus Receiving Insulin TherapyNCT02847091Change from baseline in insulin doseOpen-label · Treatment | Phase 4 | Completed | Drug: Ipragliflozin, Insulin | Type 2 Diabetes Mellitus | 103 | 2017-11-09actual | — | 2024-11-12 |
| A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking MethotrexateNCT02884635ACR20 response rateRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: ASP1707, Placebo, Methotrexate | Rheumatoid Arthritis | 72 | 2017-10-18actual | — | 2024-10-23 |
| Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female SubjectsNCT03183739Safety assessed by incidence of adverse eventsRandomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: ASP8062, Placebo | Healthy Volunteers | 36 | 2017-10-06actual | — | 2024-10-21 |
| A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With AnemiaNCT02780726Hemoglobin (Hb) Response Rate from Week 18 to Week 24Randomized · Open-label · Treatment | Phase 3 | Completed | Drug: roxadustat | Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia | 56 | 2017-08-02actual | — | 2024-10-30 |
| A Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes MellitusNCT02897219Change from baseline in HbA1cRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: ipragliflozin, Placebo · Other: Insulin Therapy | Type 1 Diabetes Mellitus | 175 | 2017-07-22actual | — | 2024-11-12 |
| A Phase 4 Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Male Subjects With Overactive Bladder (OAB) Symptoms, While Taking the Alpha Blocker for Benign Prostatic Hypertrophy (BPH)NCT02656173results2018-09-18Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 HoursRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Mirabegron, Placebo, Tamsulosin | Overactive Bladder | 568 | 2017-07-21actual | — | 2024-11-12 |
| An Open-label Phase I Study of Orally Available Novel Small-molecule Fibroblast Growth Factor Receptors (FGFR) 1,2,3 and 4 Inhibitor, ASP5878 at Single and Multiple Doses in Patients With Solid TumorsNCT02038673Dose-escalation part and Expansion part: Safety assessed by Adverse Events (AEs)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ASP5878 | Solid Tumors | 86 | 2017-07-19actual | — | 2024-10-31 |
| A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) TreatmentNCT02305849results2020-08-03Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Peficitinib, Placebo, Methotrexate | Rheumatoid Arthritis | 519 | 2017-06-20actual | — | 2024-10-28 |
| A Study of ASP8273 in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor-Naïve Patients With Non-Small Cell Lung Cancer Harboring EGFR MutationsNCT02500927Safety assessed by AEsOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies. | Drug: ASP8273 Capsules, ASP8273 Capsules A | EGFR-TKI-naïve Patients With NSCLC Harboring EGFR Activating Mutations | 31 | 2017-06-09actual | — | 2024-11-20 |
| A Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoieses Stimulating Agent (ESA) TreatmentNCT02779764Hemoglobin (Hb) Response Rate from Week 18 to Week 24Open-label · Treatment | Phase 3 | Completed | Drug: roxadustat | Hemodialysis Patients With Renal Anemia | 164 | 2017-05-16actual | — | 2024-10-31 |
| A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100NCT01534052results2018-04-27Number of Participants With Adverse Events (AEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Enzalutamide | Castration-Resistant Prostate Cancer (CRPC) | 52 | 2017-04-18actual | — | 2024-12-06 |
| A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDsNCT02308163results2020-03-16Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Peficitinib, Placebo · Biological: Etanercept | Rheumatoid Arthritis | 509 | 2017-01-23actual | — | 2024-10-28 |
| Post-marketing Surveillance of Kiklin Capsules in Hemodialysis PatientsNCT01901107observationalSafety assessed by the incidence of adverse events, physical exam and lab-tests | — | Completed | Drug: Kiklin capsules | Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis | 1,078 | Dec 2016actual | — | 2017-01-27 |
| A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1517 and Lanthanum Carbonate HydrateNCT02952040Pharmacokinetics (PK) parameter of ASP1517 in plasma: AUCINFRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: ASP1517, Lanthanum carbonate hydrate | Healthy Subjects | 18 | Dec 2016actual | — | 2017-01-25 |
| Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney TransplantationNCT02161237estimated GFRRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: Advagraf® | Kidney Transplantation | 73 | 2016-12-22actual | — | 2024-10-31 |
| Pharmacokinetics Study in Patients With Impaired Renal Function and Subjects With Normal Renal FunctionNCT02603497Pharmacokinetics (PK) parameter of ASP015K: AUCinfNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ASP015K | Patients With Impaired Renal Function | 31 | 2016-12-19actual | — | 2024-10-16 |
| A Study of Oral Dosing of ASP0456 in Patients With Chronic ConstipationNCT02809105Change from baseline in weekly mean SBM frequency during one week of administration (Part I)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: linaclotide, Placebo | Chronic Constipation | 186 | 2016-11-14actual | — | 2024-10-18 |
| Long-Term Specified Drug Use-results Survey of Betanis TabletsNCT01901120observationalOccurrence of adverse events | — | Completed | Drug: Betanis | Overactive Bladder | 1,263 | Sep 2016actual | — | 2016-11-01 |
| Pharmacokinetics Study in Patients With Impaired Hepatic FunctionNCT02586194Pharmacokinetics (PK) parameter of ASP015K: AUCinfNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ASP015K | Patients With Impaired Hepatic Function | 24 | 2016-09-27actual | — | 2024-10-16 |
| A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)NCT02179658Global cure rateRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: OPT-80, vancomycin | Clostridium Difficile | 210 | 2016-09-08actual | — | 2024-10-31 |
| Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.NCT02294396results2018-12-24Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Randomized · Open-label · Treatment | Phase 4 | Completed | Drug: Mirabegron tablet, Solifenacin tablet, Propiverine tablet, Imidafenacin tablet, Tolterodine capsule | Overactive Bladder (OAB) | 649 | 2016-09-07actual | — | 2024-10-31 |
| A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517NCT02805374Pharmacokinetics (PK) parameter of ASP1517 in Plasma: AUCinfRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: ASP1517 | Healthy Subjects | 16 | Aug 2016actual | — | 2016-08-24 |
| Post-Marketing Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Ipragliflozin in Combination With GLP-1 Receptor Agonists in Japanese Patients With Type 2 Diabetes Mellitus (T2DM)NCT02291874HbA1cOpen-label · Treatment | Phase 4 | Completed | Drug: Ipragliflozin | Type 2 Diabetes Mellitus | 100 | 2016-07-07actual | — | 2024-11-08 |
| Long-term Study of FK949E in Elderly Bipolar Disorder PatientsNCT01737268results2017-10-31Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total ScoreOpen-label · Treatment | Phase 3 | Completed | Drug: FK949E | Bipolar Disorder, Elderly | 20 | 2016-06-29actual | — | 2024-11-19 |
| Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid LeukemiaNCT02181660Safety and Tolerability assessed through adverse events to determine maximum tolerated doseOpen-label · Treatment | Phase 1 | Completed | Drug: Gilteritinib | Acute Myeloid Leukemia (AML) | 24 | 2016-06-27actual | — | 2024-11-06 |
| A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and MetforminNCT02760342Pharmacokinetics (PK) parameter of metformin in plasma: AUCinfOpen-label · Basic science | Phase 1 | Completed | Drug: peficitinib, Metformin | Healthy Subjects | 24 | 2016-06-26actual | — | 2024-10-16 |
| Pharmacokinetic Study of ASP1517 With Kremezin®NCT02693613Pharmacokinetics (PK) parameter of ASP1517: AUCinfRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: ASP1517, Kremezin® | Healthy Volunteers | 34 | Apr 2016actual | — | 2016-06-21 |
| Specified Drug Use-results Survey of Graceptor in Patients With Kidney Transplantation (Switching From Cyclosporine)NCT02160054observationalRate of treatment continuation (incidence of rejection, death, graft loss, or adverse event) | — | Completed | Drug: Graceptor® | the Maintenance Phase After Kidney Transplantation | 289 | 2016-03-31actual | — | 2024-10-21 |
| Pharmacodynamics, Pharmacokinetics, and Safety of ASP1941 in Patients With Type 1 Diabetes MellitusNCT02529449Daily profile of plasma glucose levelsRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Placebo, ASP1941 | Type 1 Diabetes Mellitus | 43 | 2016-03-19actual | — | 2024-11-12 |
| Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive EpisodesNCT02362412results2017-03-17Montgomery-Asberg Depression Rating Scale (MADRS) Total ScoreRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: FK949E | Bipolar Depression | 22 | 2016-02-06actual | — | 2024-11-15 |
| An Open Study of ASP8273 in Patients With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) MutationsNCT02192697Phase I: Safety and tolerability of ASP8273 as assessed by Dose Limiting Toxicities (DLTs)Non-randomized · Open-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies. | Drug: ASP8273 | Non-small Cell Lung Cancer | 124 | 2016-01-15actual | — | 2024-11-14 |
| Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in Anew Kidney Transplant PatientsNCT02267512efficacy failureRandomized · Open-label · Prevention | Phase 4 | Completed | Drug: ATG-F | De Novo Kidney Transplant Patients | 280 | 2015-12-31actual | — | 2024-11-01 |
| A Study of ASP4070 to Confirm Safety and Immunological Response in Patients With Pollen AllergyNCT02469688Adverse events developed after the first vaccination of the study drugRandomized · Quadruple-masked · Prevention | Phase 1 | Completed | Drug: ASP4070, Placebo | Cedar Pollinosis | 66 | 2015-11-27actual | — | 2024-10-31 |
| A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic ConstipationNCT02425722Change in weekly average of SBM frequencyRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ASP0456, Placebo | Chronic Constipation | 383 | 2015-10-31actual | — | 2024-10-18 |
| A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive BladderNCT02211846Pharmacokinetic parameter of mirabegron: CmaxOpen-label · Basic science | Phase 1 | Completed | Drug: Mirabegron | Neurogenic Detrusor Overactivity, Overactive Bladder, Pharmacokinetics of Mirabegron | 34 | 2015-09-21actual | — | 2024-10-22 |
| An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer ParticipantsNCT02294461results2017-04-12Time to Prostate-specific Antigen (PSA) ProgressionRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Enzalutamide, Placebo | Progressive Metastatic Prostate Cancer | 395 | 2015-09-20actual | — | 2025-10-24 |
| Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel SyndromeNCT02316899Responder rate of Global assessment of relief of IBS symptoms during 12 weeks.Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: linaclotide, Placebo | Irritable Bowel Syndrome With Constipation (IBS-C) | 500 | 2015-09-19actual | — | 2024-10-18 |
| A Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive EpisodesNCT01725308results2017-02-08Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total ScoreRandomized · Quadruple-masked · Treatment | Phase 2/3 | Completed | Drug: FK949E, Placebo | Bipolar Disorder | 431 | 2015-08-01actual | — | 2024-11-15 |
| The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes PatientsNCT02297620observationalSpecify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors | — | Completed | Drug: Suglat® | Type 2 Diabetes | 8,687 | Jul 2015actual | — | 2015-10-15 |
| Bioequivalence Evaluation of a New and Current Tablet of ASP015KNCT02531191Pharmacokinetics (PK) parameter of ASP015K: Area under the concentration-time curve (AUC) from the time of dosing to the time of the last sampling (AUCt)Randomized · Open-label · Other | Phase 1 | Completed | Drug: peficitinib | Healthy Volunteers | 40 | 2015-07-15actual | — | 2024-10-16 |
| ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-NCT01964196Rate of rise in Hb (g/dL/week) at Week 6Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ASP1517, Placebo | Anemia in Chronic Kidney Disease Patients Not on Dialysis | 107 | 2015-07-06actual | — | 2024-10-30 |
| A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate CancerNCT01964170Cumulative castration rate of treatment in terms of serum testosterone levelRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: degarelix, Goserelin | Prostate Cancer | 234 | 2015-06-05actual | — | 2024-10-31 |
| Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal ImpairmentNCT01981941Change in International Restless Leg Syndrome (IRLS) rating scale scoreOpen-label · Treatment | Phase 4 | Completed | Drug: Gabapentin enacarbil | Restless Legs Syndrome (RLS) | 19 | 2015-05-13actual | — | 2024-11-08 |
| Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal AllograftsNCT00933231Percentage of Participants with the Presence of Allograft Interstitial Fibrosis and Tubular Atrophy (IF/TA) as Assessed at a Central Pathology LabRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: tacrolimus, tacrolimus, Cellcept, Corticosteroids, Ramipril, Irbesartan · Biological: Simulect | Kidney Transplantation | 281 | 2015-05-11actual | — | 2024-11-01 |
| A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)NCT01511003ACR20 response rate 6 months post doseOpen-label · Treatment | Phase 4 | Completed | Drug: Tacrolimus | Rheumatoid Arthritis | 128 | 2015-05-11actual | — | 2018-08-13 |
| Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on DialysisNCT01742611Time-course changes in serum phosphorus levelsOpen-label · Treatment | Phase 3 | Completed | Drug: ASP1585 | Chronic Kidney Disease, Renal Insufficiency, Hyperphosphatemia | 105 | Apr 2015actual | — | 2015-06-09 |
| A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4NCT01409135Incidence of adverse eventsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: AGS-22M6E, ASG-22CE | Tumors, Medical Oncology, Neoplasms | 34 | 2015-04-27actual | — | 2024-03-12 |
| Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis PatientsNCT01870908observationalSimplified disease activity index (SDAI) | — | Completed | Drug: tacrolimus, biological agents | Rheumatoid Arthritis | 664 | Mar 2015actual | — | 2015-10-05 |
| A Study to Assess the Efficacy and Safety of Ipragliflozin in Combination With Insulin in Subjects With Type 2 Diabetes MellitusNCT02175784Change in HbA1C from baselineRandomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: ipragliflozin, placebo | Type 2 Diabetes Mellitus | 262 | 2015-03-31actual | — | 2024-11-08 |
| Specified Drug Use-results Survey of Betanis Tablets for Patients With Coexisting Cardiovascular DiseaseNCT02570035observationalChanges in electrocardiogram parameters pre- and post- administration of mirabegron | — | Completed | Drug: Mirabegron | Overactive Bladder, Cardiovascular Disease | 316 | Mar 2015actual | — | 2015-10-07 |
| Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida InfectionsNCT00413218results2017-08-01Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT UseRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Isavuconazole, Caspofungin, Voriconazole | Candidiasis, Invasive, Candidemia, Mycoses | 450 | 2015-03-03actual | — | 2024-12-10 |
| A Study of ASP1585 to Evaluate the Bioequivalence Between ASP1585 Granules and ASP1585 CapsulesNCT02531204Average daily amount of urine phosphorus change from baselineRandomized · Open-label | Phase 1 | Completed | Drug: ASP1585 | Healthy, Urine Phosphorus Excretion | 60 | Feb 2015actual | — | 2015-08-24 |
| A Study to Evaluate the Tolerability and Efficacy of Tamsulosin 0.4mg OCAS Formulation in Patients Who Are Unsatisfied With the Treatment of Tamsulosin 0.2mg Conventional FormulationNCT02180789Changes from baseline in total scores of International Prostate Symptom Score (IPSS)Open-label · Treatment | Phase 4 | Completed | Drug: Tamsulosin OCAS | Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) | 100 | Jan 2015actual | — | 2015-11-18 |
| A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell TransplantNCT01903928Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-testsOpen-label · Treatment | Phase 2 | Completed | Biological: ASP0113 | Allogeneic Hematopoietic Cell Transplant | 9 | 2015-01-19actual | — | 2024-10-17 |
| A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing HemodialysisNCT02133404Serum iPTH concentrationRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ASP7991, Cinacalcet, Placebo | Secondary Hyperparathyroidism | 62 | 2014-11-10actual | — | 2024-11-06 |
| Single and Multiple Dosing Study in Hemodialysis Patients With Hyperphosphatemia in JapanNCT02510274Safety assessed by adverse events: Part 1Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ASP3325 | Chronic Kidney Disease, Hyperphosphatemia Undergoing Hemodialysis | 24 | 2014-11-04actual | — | 2024-11-05 |
| A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate CancerNCT01288911results2015-12-03Progression Free Survival (PFS) Based on Independent Central Review (ICR) AssessmentRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: enzalutamide, bicalutamide | Prostatic Neoplasms | 375 | 2014-10-19actual | — | 2024-12-06 |
| A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference DrugNCT01888445Rate of rise in hemoglobin (g/dL/week)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: roxadustat, darbepoetin alfa | Renal Anemia Associated With Chronic Renal Failure (CRF) | 130 | 2014-09-15actual | — | 2024-10-30 |
| A Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)NCT00889382Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)Randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: OSI-906, Paclitaxel | Ovarian Cancer, Solid Tumors | 152 | 2014-08-01actual | — | 2024-11-20 |
| Drug Use-Results Survey of Betanis Tablets in JapanNCT01919047observationalOccurrence of adverse events and adverse drug reactions | — | Completed | Drug: Betanis | Overactive Bladder | 10,711 | Jul 2014actual | — | 2015-10-05 |
| A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia GravisNCT01325571Change from baseline in quantitative myasthenia gravis (QMG) score for disease severityRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Tacrolimus capsule, Placebo | Myasthenia Gravis | 83 | May 2014actual | — | 2016-03-09 |
| A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel SyndromeNCT01736423Monthly responder rate of global assessment of relief of overall IBS symptomsOpen-label · Treatment | Phase 3 | Completed | Drug: YM060 | Diarrhea-predominant Irritable Bowel Syndrome | 151 | May 2014actual | — | 2015-10-12 |
| A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on DialysisNCT01742585Change from baseline in serum phosphorus level at the end of treatmentRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ASP1585, placebo | Chronic Kidney Disease, Renal Insufficiency, Hyperphosphatemia | 163 | May 2014actual | — | 2014-07-16 |
| A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver TransplantationNCT01339468AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentrationRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: Advagraf, Prograf, Prograf | Liver Transplantation | 100 | 2014-05-27actual | — | 2017-07-19 |
| A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate HyperplasiaNCT02038868Change from baseline in total IPSS (International Prostate Symptom Score)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ASP4901, Tamsulosin, Placebo | Benign Prostate Hyperplasia | 320 | 2014-04-04actual | — | 2024-11-06 |
| Study of an Investigational Drug, ASP3026, in Patients With Advanced Malignancies (Solid Tumors and B-Cell Lymphoma)NCT01284192Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observationsOpen-label · Treatment | Phase 1 | Completed | Drug: ASP3026 | Advanced Malignancies, Positive for Anaplastic Lymphoma Kinase, Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS, Solid Tumor, B-Cell Lymphoma | 46 | Feb 2014actual | — | 2016-06-28 |
| A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic PatientsNCT01478607Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scaleRandomized · Single-masked · Treatment | Phase 3 | Completed | Drug: QUTENZA | Painful Diabetic Peripheral Neuropathy (PDPN) | 468 | Feb 2014actual | — | 2015-10-14 |
| A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)NCT01533428results2015-03-13Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Capsaicin 8%, Placebo | Diabetic Peripheral Neuropathy, Pain | 369 | Feb 2014actual | — | 2015-11-04 |
| A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)NCT01870895Monthly responder rate of global assessment of relief of overall IBS symptoms at final pointRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: YM060, Placebo | Diarrhea-predominant Irritable Bowel Syndrome | 577 | Feb 2014actual | — | 2015-10-12 |
| A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to MethotrexateNCT01554696Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) responseRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: peficitinib, Placebo, methotrexate | Arthritis, Rheumatoid | 379 | 2014-02-11actual | — | 2025-05-29 |
| Study of an Investigational Drug, ASP3026, in Patients With Solid TumorsNCT01401504Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observationsOpen-label · Treatment | Phase 1 | Completed | Drug: ASP3026 | Solid Tumor | 29 | Jan 2014actual | — | 2014-06-11 |
| A Study to Compare the Oral Absorption of ASP1941 Among Two Types of TabletsNCT01972880Plasma concentration of unchanged ASP1941Randomized · Open-label | Phase 1 | Completed | Drug: ASP1941 | Healthy, Plasma Concentration of ASP1941 | 32 | Jan 2014actual | — | 2014-02-07 |
| Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare FungiNCT00634049results2016-01-11Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).Open-label · Treatment | Phase 3 | Completed | Drug: isavuconazole | Aspergillosis, Invasive Fungal Infections | 149 | 2014-01-03actual | — | 2024-12-11 |
| A Single and Multiple Oral Dose Study and a Treatment Schedule-finding Study in Non-elderly, Healthy SubjectsNCT02500953Safety developed by adverse events, Part 1Randomized · Triple-masked | Phase 1 | Completed | Drug: ASP3325, Placebo | Pharmacokinetics of ASP3325 in Non-elderly, Healthy Adult Japanese Male and Female, and Caucasian Male Subjects | 124 | Dec 2013actual | — | 2015-07-17 |
| A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel SyndromeNCT01714843Global assessment of relief of IBS symptoms ResponderRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: linaclotide, placebo | Constipation-predominant Irritable Bowel Syndrome (IBS-C) | 559 | 2013-12-07actual | — | 2024-10-18 |
| Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®NCT01332201determine steady state systemic exposure (AUC 0-24h)Randomized · Open-label · Prevention | Phase 2 | Completed | Drug: Advagraf, Prograf | Heart Transplantation, Lung Transplantation, Pancreas (Including SPK) Transplantation | 17 | Nov 2013actual | — | 2015-06-16 |
| A Study to Evaluate the Safety of ASP2408 After Subcutaneous Administration to Healthy Male SubjectsNCT02140125Safety assessed by the incidence of adverse events, vital signs, lab tests, and 12-lead ECGRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: ASP2408, Placebo | Healthy, Pharmacokinetics of ASP2408 | 24 | Oct 2013actual | — | 2014-07-01 |
| A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical ProstatectomyNCT01371994results2014-10-09Time From First Dose to Urinary ContinenceRandomized · Triple-masked · Treatment | Phase 4 | Completed | Drug: solifenacin succinate, Placebo | Urinary Incontinence | 640 | 2013-10-21actual | — | 2024-11-21 |
| Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve DamageNCT01252160Adverse events (AEs)Open-label · Treatment | Phase 4 | Completed | Drug: QUTENZA | Neuralgia, Postherpetic | 306 | 2013-09-26actual | — | 2018-04-19 |
| A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.NCT01363752Glomerular Filtration Rate (GFR) estimated by iohexol clearance at Week 52 post kidney transplantationRandomized · Open-label · Prevention | Phase 4 | Completed | Drug: Advagraf, Mycophenolate Mofetil, Sirolimus, Corticosteroids | Kidney Transplantation | 853 | 2013-09-18actual | — | 2024-10-31 |
| Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of TolterodineNCT01964183Plasma concentration of unchanged mirabegronOpen-label | Phase 4 | Completed | Drug: tolterodine, mirabegron | Pharmacokinetics of Mirabegron and Tolterodine, Healthy | 24 | Aug 2013actual | — | 2013-10-17 |
| Efficacy Confirmation Study of CDP870 in Early Rheumatoid ArthritisNCT01451203results2015-11-20Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Placebo, CZP, methotrexate (MTX) | Rheumatoid Arthritis | 319 | 2013-08-28actual | — | 2024-12-09 |
| Study to Evaluate the Effect and Safety of Quetiapine Extended Release (XR) (FK949E) in Major Depressive DisorderNCT01725282results2014-08-28Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total ScoreRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: quetiapine extended release (XR), Placebo | Major Depressive Disorder | 172 | 2013-08-24actual | — | 2024-11-15 |
| A Study to Evaluate the Effect of ASP8597 in Adult Kidney Transplant PatientsNCT01442337Pharmacokinetic (PK) variable for ASP8597: Maximum concentration (Cmax)Randomized · Quadruple-masked · Prevention | Phase 2/3 | Terminatedsponsor's stated reason: Study was terminated by sponsor decision | Drug: ASP8597, Placebo | Kidney Transplantation | 21 | Jul 2013actual | — | 2014-06-20 |
| A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder PatientsNCT01745094results2018-02-28Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 4 | Completed | Drug: mirabegron, solifenacin | Overactive Bladder | 223 | 2013-07-23actual | — | 2018-02-28 |
| A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis SubjectsNCT01649999Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) responseRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: peficitinib, Placebo | Arthritis, Rheumatoid | 281 | 2013-07-20actual | — | 2024-10-21 |
| Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Placebo Plus Erlotinib in Patients With Nonprogression Following 4 Cycles of Platinum-based ChemotherapyNCT01186861The Progression Free Survival (PFS) of maintenance OSI-906 plus erlotinib, or placebo plus erlotinib in patients with nonprogression following four cycles of first-line platinum-based chemotherapy for advanced NSCLC in the overall populationRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: OSI-906, erlotinib, placebo | Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy | 205 | 2013-07-01actual | — | 2025-11-18 |
| Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) PatientsNCT00851318results2014-09-17Number of Participants With Adverse EventsRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Certolizumab pegol, Methotrexate | Rheumatoid Arthritis | 285 | Jun 2013actual | — | 2014-11-03 |
| Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing HemodialysisNCT01872026The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and ophthalmic examinationNon-randomized · Open-label · Other | Phase 1 | Completed | Drug: ASP7991 | Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy, Pharmacodynamics of ASP7991, Pharmacokinetics of ASP7991 | 14 | 2013-06-26actual | — | 2024-11-06 |
| Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) PatientsNCT00850343results2014-09-17Number of Participants With Adverse EventsRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Certolizumab pegol | Rheumatoid Arthritis | 208 | May 2013actual | — | 2014-11-03 |
| A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis PatientsNCT01342016remission rate (partial remission + complete remission)Randomized · Quadruple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Due to safety concern of active control drug | Drug: tacrolimus capsule, tacrolimus placebo, leflunomide tablet, leflunomide placebo, prednisone | Lupus Nephritis | 84 | May 2013actual | — | 2014-10-17 |
| A Study to Demonstrate Safety and Efficacy of Advagraf in Patients Undergoing Kidney or Liver Transplantation in IndiaNCT02432053Renal function (evaluated by level of Serum Creatinine)Open-label · Treatment | Phase 4 | Completed | Drug: Advagraf | Kidney Transplantation, Liver Transplantation | 92 | May 2013actual | — | 2015-05-01 |
| Long-term Treatment Study of CDP870 Self-injection in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870NCT02586246Percentage of subjects experiencing at least one adverse event or at least one serious adverse event during the studyNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: CDP870 | Active Rheumatoid Arthritis | 86 | May 2013actual | — | 2015-11-16 |
| Reproducibility Study of OABSS and Its Response to TreatmentNCT02667470Change in OABSS scores from prior to treatment and after treatmentOpen-label · Treatment | Phase 4 | Completed | Drug: Solifenacin | Overactive Bladder | 50 | May 2013actual | — | 2016-01-29 |
| A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without SteroidsNCT01304836Diagnosis of new onset Diabetes Mellitus as per ADA criteria at any point up to 24 weeks after kidney transplantationRandomized · Open-label · Prevention | Phase 4 | Completed | Drug: Advagraf, Mycophenolate Mofetil, Simulect, Corticosteroids | Kidney Transplantation | 1,166 | 2013-05-22actual | — | 2024-11-01 |
| Celecoxib Japan Observational Study for the Patients With Acute PainNCT01876121observationalSafety assessed by the incidence of adverse events and lab-tests | — | Completed | Drug: Celecoxib | Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract Pain | 784 | Apr 2013actual | — | 2014-09-05 |
| A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes PatientsNCT01672762Change in HbA1cOpen-label · Treatment | Phase 3 | Completed | Drug: ipragliflozin | Type 2 Diabetes Mellitus | 174 | 2013-04-13actual | — | 2024-11-08 |
| A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior TreatmentNCT01007292Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)Open-label · Treatment | Phase 2 | Completed | Drug: YM155 · Biological: Rituximab | Non-Hodgkin's Lymphoma | 43 | Mar 2013actual | — | 2015-10-19 |
| Isavuconazole (BAL8557) for Primary Treatment of Invasive AspergillosisNCT00412893results2015-03-31All-cause Mortality Through Day 42Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Isavuconazole, Voriconazole | Aspergillosis, Invasive Fungal Infection | 527 | 2013-03-28actual | — | 2024-12-10 |
| Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) GeneNCT01221077Progression-free survival of OSI-906 in combination with Erlotinib or Erlotinib plus placeboRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: OSI-906, Erlotinib, Placebo | NSCLC, Non Small Cell Lung Cancer | 88 | 2013-03-01actual | — | 2025-11-18 |
| Study of Oral OSI-027 in Patients With Advanced Solid Tumors or LymphomaNCT00698243Maximum tolerated doseNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: OSI-027 | Any Solid Tumor or Lymphoma | 128 | Feb 2013actual | — | 2013-04-15 |
| A Study to Determine the Maximum Tolerated Dose of ASG-5ME in Subjects With Castration-Resistant Prostate CancerNCT01228760Safety assessed by recording of adverse events, laboratory assessments and vital signsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ASG-5ME | Prostate Neoplasms | 46 | Feb 2013actual | — | 2013-06-07 |
| A Clinical Study to Investigate the Efficacy, Safety and Pharmacokinetics of ASP3652 in Patients With Chronic Abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS)NCT01391338Change from baseline in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), total score at 12 weeksRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ASP3652, Placebo | Chronic Abacterial Prostatitis, Chronic Pelvic Pain Syndrome | 239 | Feb 2013actual | — | 2013-03-21 |
| Multiple Oral Administration of ASP7991 to Non-elderly Male SubjectsNCT01872013The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and slit lamp examinationRandomized · Quadruple-masked | Phase 1 | Completed | Drug: ASP7991, Placebo | Healthy, Pharmacokinetics of ASP7991 | 36 | Feb 2013actual | — | 2013-06-07 |
| Efficacy and Safety of Dorner Tablets and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus PatientsNCT02786979Change from baseline in carotid intima-media thicknessRandomized · Open-label · Prevention | Phase 4 | Terminatedsponsor's stated reason: Upon interim analysis, sponsor's decision due to absence of demonstration of efficacy. | Drug: Beraprost, Aspirin | Type 2 Diabetes Mellitus | 190 | Jan 2013actual | — | 2016-06-21 |
| A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes PatientsNCT01505426Change in HbA1c from baseline to end of treatmentRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ASP1941, metformin, Placebo | Type II Diabetes Mellitus | 171 | 2013-01-14actual | — | 2024-11-12 |
| Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver TransplantationNCT01011205Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formulaRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Advagraf, Mycophenolate Mofetil, Basiliximab, Corticosteroids | Liver Transplantation | 893 | 2013-01-04actual | — | 2024-11-01 |
| A First in Man Study to Determine the Safety at Various Dose Levels of AGS-16M8F in Advanced Kidney CancerNCT01114230Safety assessed by recording adverse events, vital signs and laboratory assessmentsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: AGS-16M8F | Renal Cell Carcinoma, Pharmacokinetics of AGS-16M8F | 26 | Nov 2012actual | — | 2012-12-12 |
| A Study to Assess the Safety and Pharmacokinetics of Isavuconazole in Healthy Chinese VolunteersNCT01555918Composite of pharmacokinetics of isavuconazole in plasma (Part 1): Cmax, AUClast, AUCinf, AUC24, tmax, t1/2, CL/F, Vz/F, F, MRT, CLtot, and VzRandomized · Open-label | Phase 1 | Completed | Drug: Isavuconazole, Isavuconazole (IV) | Pharmacokinetics of BAL4815, Pharmacokinetics of BAL8728, Healthy Volunteers | 36 | Nov 2012actual | — | 2013-02-01 |
| A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal ImpairmentNCT01316094changes in Hemoglobin A1c (HbA1c)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ASP1941, placebo | Type 2 Diabetes Mellitus | 165 | 2012-11-28actual | — | 2025-05-22 |
| A Study to Evaluate Absorption, Distribution and Elimination of Mirabegron After Oral Administration to Non-elderly Healthy Chinese SubjectsNCT01747564Pharmacokinetic (PK) profile for ASP015K (in plasma): Cmax, AUClast, AUCinf and AUC0-24hOpen-label | Phase 1 | Completed | Drug: YM178 (mirabegron) | Healthy Subjects, Plasma Concentration of Mirabegron | 24 | Oct 2012actual | — | 2012-12-11 |
| A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic PatientsNCT01316107change from baseline in hemoglobin A1c (HbA1c)Open-label · Treatment | Phase 3 | Completed | Drug: ipragliflozin, nateglinide | Type 2 Diabetes Mellitus | 122 | 2012-10-19actual | — | 2025-05-30 |
| A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes MellitusNCT01514838Change in HbA1c from baseline to end of treatmentRandomized · Quadruple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Discontinued due to company's strategic reason | Drug: ASP1941, acarbose, Placebo | Type II Diabetes Mellitus | 46 | 2012-10-19actual | — | 2024-11-12 |
| Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) PatientsNCT01352208To evaluate the safety and tolerability, based on the frequency and severity of Adverse Events (AEs), laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observationsOpen-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: It was decided to discontinue the development in consideration of the results of a P1 study | Drug: ASP9521 | Castrate Resistant Prostate Cancer | 13 | Sep 2012actual | — | 2014-03-24 |
| Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive BladderNCT01539707Maximum concentration (Cmax)Non-randomized · Open-label · Other | Phase 1 | Completed | Drug: Solifenacin succinate suspension 5 mg | Overactive Bladder, Neurogenic Detrusor Overactivity | 14 | 2012-08-13actual | — | 2024-10-22 |
| A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone TherapyNCT01302041results2016-04-06Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25Open-label · Treatment | Phase 2 | Completed | Drug: Enzalutamide | Prostate Cancer | 67 | 2012-07-29actual | — | 2018-10-02 |
| A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer PatientsNCT01284920Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGCNon-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: MDV3100 | Prostate Cancer, Prostate Neoplasms, Castration Resistant Prostate Cancer (CRPC) | 47 | 2012-07-12actual | — | 2024-11-21 |
| A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical CarcinomaNCT00924989Overall survival of single agent OSI-906 versus placeboRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: OSI-906 · Other: Placebo | Adrenocortical Carcinoma | 139 | 2012-07-11actual | — | 2024-11-20 |
| A Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging (MPI) Using Multidetector Computed Tomography (MDCT) Compared to Single Photon Emission Computed Tomography (SPECT)NCT01334918results2013-09-18Number of Participants With Reversible DefectsRandomized · Open-label · Diagnostic | Phase 2 | Completed | Drug: regadenoson · Radiation: technetium Tc99m sestamibi /technetium Tc99m tetrafosmin, Contrast · Procedure: Single Photon Emission Computed Tomography, Multidetector Computed Tomography | Coronary Artery Disease (CAD) | 124 | 2012-07-02actual | — | 2024-12-04 |
| A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast CancerNCT01038804Progression free survival (PFS)Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: YM155, Docetaxel | Breast Cancer | 101 | Jun 2012actual | — | 2013-09-18 |
| A Study to Assess the Safety, Pharmacological Effect and Plasma Concentration of ASP7991 After Single Oral Administration to Healthy VolunteersNCT01675518The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGsRandomized · Quadruple-masked | Phase 1 | Completed | Drug: ASP7991, Placebo | Healthy, Pharmacokinetics of ASP7991 | 56 | Jun 2012actual | — | 2012-08-30 |
| Comparison of Plasma Concentration Changes Between Two Types of Tablets of FK949E Administration to Patients With Major Depressive DisorderNCT01919008Maximum plasma concentration (Cmax) of unchanged quetiapineRandomized · Open-label · Other | Phase 1 | Completed | Drug: FK949E | Major Depressive Disorder | 16 | 2012-06-22actual | — | 2024-10-31 |
| A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic PatientsNCT01242228Change from baseline in HbA1cOpen-label · Treatment | Phase 3 | Completed | Drug: ipragliflozin, DPP-4 inhibitor | Type 2 Diabetes Mellitus | 106 | 2012-06-06actual | — | 2025-05-30 |
| A Pilot Trial in a Sleep Laboratory Setting to Observe Night Time Bladder Function of Subjects With Overactive Bladder (OAB)NCT01099345observationalAverage nocturia individual volume void | — | Terminatedsponsor's stated reason: Slow Enrollment | Procedure: cystometry (CMG), polysomnography (PSG) | Bladder Function | 15 | May 2012actual | — | 2014-06-04 |
| A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic PatientsNCT01242202Change from baseline in HbA1cOpen-label · Treatment | Phase 3 | Completed | Drug: ipragliflozin, alpha glucosidase inhibitor | Type 2 Diabetes Mellitus | 113 | 2012-05-25actual | — | 2025-05-30 |
| Liver Transplant European Study Into the Prevention of Fungal InfectionNCT01058174'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).Randomized · Open-label · Prevention | Phase 3 | Completed | Drug: micafungin, fluconazole, liposomal amphotericin B, caspofungin | Liver Transplantation, Mycoses | 350 | 2012-05-03actual | — | 2024-11-18 |
| A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic CancerNCT00902291Survival rate at 6 monthsRandomized · Open-label · Treatment | Phase 2 | Completed | Biological: AGS-1C4D4, Gemcitabine | Carcinoma, Pancreatic Ductal, Pancreatic Cancer, Pancreatic Disease | 205 | Apr 2012actual | — | 2015-09-14 |
| A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Pioglitazone in Type 2 Diabetic PatientsNCT01225081Change from baseline in HbA1cRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ipragliflozin, Placebo, Pioglitazone | Type 2 Diabetes Mellitus | 152 | 2012-04-28actual | — | 2025-05-30 |
| A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Sulfonylurea in Type 2 Diabetic PatientsNCT01242215Change from baseline in HbA1cRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Device: ipragliflozin · Drug: Placebo, Sulfonylurea | Type 2 Diabetes Mellitus | 243 | 2012-04-25actual | — | 2025-05-30 |
| Method of Pre-treatment for Application of QUTENZA Capsaicin 8% PatchNCT01416116The proportion of subjects who tolerate QUTENZA treatmentRandomized · Single-masked · Treatment | Phase 4 | Completed | Drug: QUTENZA, Lidocaine, Tramadol | or Peripheral Nerve Injury (PNI), Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) | 122 | 2012-04-25actual | — | 2018-04-23 |
| Study to Find Maintenance Dose for Periodic Administration of ASP3550NCT01261572Change in proportion of patients with serum testosterone ≤0.5 ng/mL over timeRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: degarelix | Prostatic Neoplasms | 155 | 2012-04-24actual | — | 2024-10-31 |
| Special Drug Use-Results Survey of Lipitor TabletsNCT01446679observationalChanges in plasma LDL-C concentration | — | Completed | Drug: atrovastatin | Hypercholesterolemia | 24,050 | Mar 2012actual | — | 2013-02-21 |
| Study of Continuous OSI-906 DosingNCT00514007Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of oral OSI-906Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: OSI-906 | Advanced Solid Tumors | 95 | 2012-03-19actual | — | 2024-11-20 |
| A Phase 1 Dose-escalation Study of OSI-906 and Erlotinib (Tarceva®)NCT00739453Determine the maximum tolerated dose (MTD) and recommended phase 2 dose of OSI-906 and erlotinibNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: OSI-906, erlotinib | Advanced Solid Tumors | 95 | 2012-03-03actual | — | 2024-11-20 |
| Assessment and Tracking of Long-term Alefacept SafetyNCT00454701observationalTo measure the rates of non-Hodgkin's lymphoma (NHL) and infections that require hospitalization occurring in psoriasis patients treated with alefacept | — | Terminatedsponsor's stated reason: The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive | Drug: Alefacept exposure | Psoriasis | 1,897 | Feb 2012actual | — | 2013-12-11 |
| Safety and Pharmacokinetics (PK) of Alefacept in Adolescent Subjects With Moderate to Severe PsoriasisNCT00808223Assessment of Physical exams, vital signs, select blood chemistry and hematology, lymphocyte subset analysis, anti-alefacept antibody monitoring, adverse event monitoring including infections.Non-randomized · Open-label · Treatment | Phase 2 | Completed | Biological: alefacept | Psoriasis | 30 | Feb 2012actual | — | 2013-12-12 |
| Drug Interaction Study of Isavuconazole and TacrolimusNCT01535547Composite of Pharmacokinetic (PK) variables for tacrolimus (in whole blood) : AUClast , AUCinf, Cmax, tmax , Vz /F, CL/F and t1/2Open-label | Phase 1 | Completed | Drug: isavuconazole, tacrolimus | Pharmacokinetics of Isavuconazole, Pharmacokinetics of Tacrolimus, Healthy Volunteers | 24 | Jan 2012actual | — | 2012-02-17 |
| A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney TransplantationNCT01279538Pharmacokinetic assessment through analysis of blood samplesRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: bleselumab, Placebo | Kidney Transplantation | 50 | 2012-01-23actual | — | 2025-11-17 |
| AMEVIVE® Pregnancy RegistryNCT00342862observationalEvaluate pattern or increase in major birth defects in children of women w/ psoriasis who were exposed to AMEVIVE® at any time within the 8 wks prior to conception, or at any time during pregnancy, where outcome of the pregnancy is unknown prospectively | — | Terminatedsponsor's stated reason: The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive | Drug: Amevive exposure | Pregnancy | 3 | Dec 2011actual | — | 2013-12-11 |
| Drug Interaction Study of Isavuconazole and CyclosporineNCT01494597Composite of Pharmacokinetic (PK) variables for cyclosporine (in whole blood): Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to the last quantifiable concentration (AUClast), CmaxOpen-label | Phase 1 | Completed | Drug: isavuconazole, cyclosporine | Healthy | 24 | Dec 2011actual | — | 2011-12-19 |
| A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical SubjectsNCT01122368The incidence of Invasive Fungal InfectionRandomized · Quadruple-masked · Prevention | Phase 2 | Completed | Drug: micafungin, placebo | Mycoses | 252 | 2011-12-15actual | — | 2024-11-19 |
| A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Type 2 Diabetic PatientsNCT01135433Change from baseline in HbA1cRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ipragliflozin, Placebo, metformin | Type 2 Diabetes Mellitus | 168 | 2011-11-28actual | — | 2025-05-30 |
| A Randomized, Placebo-controlled, Double-blind Phase 2 Study With OSI-906 in Patients With Advanced HCCNCT01101906Time to progression (TTP)Randomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Company decided not to pursue the development of this drug in this patient population at this time | Drug: OSI-906, Placebo | Advanced Hepatocellular Carcinoma (HCC) | 23 | 2011-11-04actual | — | 2024-11-20 |
| A Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease (AD) Taking a Stable Dose of DonepezilNCT01406145Number and percentage of subjects with adverse eventsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: ASP0777, Placebo | Alzheimer's Disease | 60 | 2011-11-04actual | — | 2024-10-30 |
| A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female PatientsNCT01274000Responder rate of patients reported global assessment of relief of IBS symptomsRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: YM060, placebo | Irritable Bowel Syndrome | 409 | Oct 2011actual | — | 2015-10-12 |
| A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating AbataceptNCT01339481observationalCD86 Receptor Occupancy | — | Completed | Drug: abatacept | Rheumatoid Arthritis | 26 | Oct 2011actual | — | 2011-11-29 |
| A Single Oral Dose Study to Compare the Bioavailability Between Two Different Tablet Formulations and Assess if There is a Food Effect With the New FormulationNCT01484964Composite of pharmacokinetic parameters of ASP015K: C max, AUClast, and AUCinfRandomized · Open-label | Phase 1 | Completed | Drug: ASP015K | Pharmacokinetics of ASP015K, Bioavailability of ASP015K, Healthy Subjects | 24 | Oct 2011actual | — | 2011-12-05 |
| A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin TreatmentNCT01318837Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)Non-randomized · Open-label | Phase 4 | Completed | Drug: solifenacin | Over Active Bladder | 100 | Sep 2011actual | — | 2014-07-10 |
| Study to Compare Pharmacokinetic Profiles of TRK-100STP in Japanese, Chinese, and South Korean Non-elderly Healthy Adult MalesNCT01423435Composite of pharmacokinetic parameters of TRK-100STP such as maximum observed concentration (Cmax), area under the serum concentration-time curve (AUC) and terminal half-life (t1/2)Non-randomized · Open-label | Phase 1 | Completed | Drug: TRK-100STP | Healthy Adult Male, Pharmacokinetics of TRK-100-STP | 36 | Sep 2011actual | — | 2011-10-04 |
| A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy SubjectsNCT01427387Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) of ASP0456 assessed by its plasma concentration changeRandomized · Triple-masked | Phase 1 | Completed | Drug: ASP0456, Placebo | Healthy, Pharmacokinetics of ASP0456 | 44 | Sep 2011actual | — | 2011-09-23 |
| A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015KNCT01486017Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinfRandomized · Open-label | Phase 1 | Completed | Drug: ASP015K | Bioavailability of ASP015K, Pharmacokinetics of ASP015K, Healthy Subjects | 30 | Sep 2011actual | — | 2011-12-06 |
| Study to Evaluate Safety and Tolerability of FK949E in Elderly Patients With Major Depressive DisorderNCT01903200Maximum plasma concentration (Cmax) of unchanged quetiapineNon-randomized · Open-label · Other | Phase 1 | Completed | Drug: FK949E | Major Depressive Disorder Patients | 16 | Sep 2011actual | — | 2017-02-16 |
| A Study of YM178 in Subjects With Symptoms of Overactive BladderNCT01043666Change in mean number of micturitions per 24 hrsRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: YM178, Placebo, tolterodine ER | Urinary Bladder, Overactive | 1,126 | 2011-09-16actual | — | 2024-10-31 |
| Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the DrugNCT00608335PK parameters (AUCtau, Tmax, and Cmax)Non-randomized · Open-label · Other | Phase 1 | Completed | Drug: Micafungin | Oropharyngeal Candidiasis, Candidemia, Invasive Candidiasis, Esophageal Candidiasis | 84 | 2011-09-08actual | — | 2024-11-18 |
| Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder PatientsNCT00985387observationalpercentage of patients who are maintaining solifenacin treatment | — | Completed | Drug: Solifenacin | Urinary Bladder, Overactive, Overactive Bladder | 1,215 | Aug 2011actual | — | 2011-10-12 |
| A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male PatientsNCT01225237Responder rate of stool form normalizationRandomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: Ramosetron, Placebo | Irritable Bowel Syndrome | 296 | Aug 2011actual | — | 2014-10-15 |
| A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet and Conventional Tablet Under With Water IntakeNCT01394653Area under the curve of YM060 plasma concentration -time curveRandomized · Open-label | Phase 1 | Completed | Drug: YM060 | Healthy, Plasma Concentration of YM060 | 36 | Aug 2011actual | — | 2011-10-12 |
| A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma ConcentrationNCT01403818Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration changeRandomized · Open-label | Phase 1 | Completed | Drug: ASP1941, Mitiglinide calcium hydrate | Healthy, Pharmacokinetics of ASP1941, Pharmacokinetics of Mitiglinide | 60 | Aug 2011actual | — | 2011-10-12 |
| Study to Evaluate the Effect of Multiple-dose of Fluvoxamine on the Plasma Concentration of Quetiapine (FK949E) in Healthy Male VolunteersNCT01908296Maximum plasma concentration (Cmax) of unchanged quetiapineOpen-label · Other | Phase 1 | Completed | Drug: FK949E, fluvoxamine | Healthy, Pharmacokinetics of Quetiapine | 24 | Aug 2011actual | — | 2017-02-16 |
| Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and AdolescentsNCT01262391Maximum Concentration (Cmax)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Solifenacin succinate suspension 2.5 mg, Solifenacin succinate suspension 5 mg, Solifenacin succinate suspension 10 mg | Urinary Bladder, Overactive | 42 | 2011-08-14actual | — | 2024-10-22 |
| A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet FormulationNCT01406158Pharmacokinetic assessment of AUC and maximum concentration (Cmax) through the analysis of blood samplesRandomized · Open-label | Phase 1 | Completed | Drug: Solifenacin Succinate Formulation A, Solifenacin Succinate Formulation B, Solifenacin Succinate | Pharmacokinetics of Solifenacin Succinate, Healthy Volunteers | 24 | Jul 2011actual | — | 2011-08-24 |
| A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe PsoriasisNCT01096862Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) scoreRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: peficitinib, Placebo | Psoriasis | 124 | 2011-07-27actual | — | 2024-10-21 |
| A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic PatientsNCT01054092HbA1cRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: ipragliflozin | Type 2 Diabetes Mellitus | 182 | 2011-07-22actual | — | 2025-05-30 |
| A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARDNCT00378690Time to PSA progressionRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: leuprorelin acetate | Prostate Cancer | 706 | Jun 2011actual | — | 2014-06-04 |
| A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy PatientsNCT01224028Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Tacrolimus, Placebo | IgA Nephropathy | 40 | Jun 2011actual | — | 2014-08-21 |
| Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to MethotrexateNCT01224041ACR20 response rate compared to baselineOpen-label · Treatment | Phase 4 | Completed | Drug: Tacrolimus | Rheumatoid Arthritis | 78 | Jun 2011actual | — | 2015-12-29 |
| A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy VolunteersNCT01334905Maximum plasma concentration (Cmax) of YM178Randomized · Open-label | Phase 1 | Completed | Drug: YM178 | Healthy Volunteer, Pharmacokinetics of YM178 | 12 | Jun 2011actual | — | 2013-06-12 |
| Drug Interaction Study of Isavuconazole and MidazolamNCT01406171Pharmacokinetic assessment of AUC through the analysis of blood samplesOpen-label | Phase 1 | Completed | Drug: Isavuconazole, Midazolam | Pharmacokinetics of Isavuconazole, Pharmacokinetics of Midazolam, Healthy Volunteers | 24 | Jun 2011actual | — | 2011-08-01 |
| Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.NCT01093534results2014-04-07Change From Baseline to Week 12 in Bladder Wall ThicknessRandomized · Triple-masked · Basic science | Phase 4 | Completed | Drug: Placebo, solifenacin | Detrusor Overactivity, Overactive Bladder | 547 | 2011-06-23actual | — | 2024-12-03 |
| A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional TabletNCT01392794Area under the curve of YM060 plasma concentration -time curveRandomized · Open-label | Phase 1 | Completed | Drug: YM060 | Healthy, Plasma Concentration of YM060 | 36 | May 2011actual | — | 2011-07-13 |
| Oral Multiple-dose Study in Patients With Major Depressive DisorderNCT01924520Maximum plasma concentration (Cmax) of unchanged quetiapineNon-randomized · Open-label · Other | Phase 1 | Completed | Drug: FK949E | Major Depressive Disorder | 32 | May 2011actual | — | 2017-02-16 |
| A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia PatientsNCT01181232Rest/activity cycles measured by ActigraphyRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: Zolpidem MR, Zolpidem IR | Sleep Initiation and Maintenance Disorders, Primary Insomnia | 132 | Apr 2011actual | — | 2014-09-10 |
| Post Marketing Survey of Vesicare in JapanNCT01489709observationalChanges in OAB-q (overactive bladder questionnaire) | — | Completed | Drug: Vesicare | Overactive Bladder | 1,160 | Apr 2011actual | — | 2014-09-05 |
| A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes MellitusNCT01071850Mean change from baseline in Hemoglobin A1c (HbA1c)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ipragliflozin, Metformin, Placebo | Diabetes Mellitus, Type 2 | 412 | 2011-04-11actual | — | 2025-05-22 |
| A Study to Evaluate the Effect of ASP1941 in Combination With Metformin in Adult Patients With Type 2 Diabetes MellitusNCT01117584Change from baseline in HbA1c at Week 12Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ipragliflozin, Placebo, Metformin | Type 2 Diabetes Mellitus | 343 | 2011-04-01actual | — | 2025-05-22 |
| An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155NCT00818480Assess Response RateNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: YM155 | Prostate Cancer, Melanoma, Non-Hodgkin's Lymphoma | 10 | Mar 2011actual | — | 2015-09-04 |
| A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV MelanomaNCT010097756-month Progression-free survivalOpen-label · Treatment | Phase 2 | Completed | Drug: YM155, Docetaxel | Melanoma | 64 | Mar 2011actual | — | 2015-09-04 |
| A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese SubjectsNCT01373060Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECGRandomized · Quadruple-masked | Phase 1 | Completed | Drug: ASP1941, Placebo | Healthy, Pharmacokinetics of ASP1941 | 56 | Mar 2011actual | — | 2011-10-12 |
| A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant RecipientsNCT00543569results2015-12-11Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local ReviewRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: Alefacept, tacrolimus, basiliximab, mycophenolate mofetil, Corticosteroids | Kidney Transplantation | 323 | Feb 2011actual | — | 2015-12-11 |
| A Study of the Effect of ASP1941 on Cardiac Repolarization in Healthy SubjectsNCT01232413QTcF evaluated through electrocardiogram analysis (ECG)Randomized · Triple-masked | Phase 1 | Completed | Drug: Placebo, ASP1941, Moxifloxacin | Healthy Subjects, Cardiac Repolarization | 88 | Feb 2011actual | — | 2011-02-28 |
| A Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research SubjectsNCT01284309Change from baseline to Day 56 in subject-average intraocular pressure (IOP)Randomized · Quadruple-masked | Phase 1 | Completed | Drug: Mirabegron, Placebo | Intraocular Pressure | 321 | Feb 2011actual | — | 2013-12-11 |
| A Study to Evaluate Cardiovascular Interactions Between Mirabegron and TamsulosinNCT01489696Cardiovascular interactions assessed by blood pressure and pulse rateRandomized · Open-label | Phase 1 | Completed | Drug: mirabegron, tamsulosin | Cardiovascular, Healthy Subjects, Pharmacokinetics | 48 | Feb 2011actual | — | 2013-12-09 |
| Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque PsoriasisNCT00795353observationalAssess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis | — | Terminatedsponsor's stated reason: The study was terminated early due to insufficient subject enrolment in order to meet the primary and secondary endpoints | Drug: Amevive exposure | Chronic Plaque Psoriasis | 64 | Jan 2011actual | — | 2013-02-28 |
| A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to TreatmentNCT01122563observationalOABSS | — | Completed | Drug: Solifenacin | Overactive Bladder | 55 | Jan 2011actual | — | 2011-01-13 |
| A Safety and Pharmacokinetics Study of ASP0456 in Healthy SubjectsNCT01279915Pharmacokinetics of ASP0456 assessed by its plasma concentration changeRandomized · Triple-masked | Phase 1 | Completed | Drug: ASP0456, Placebo | Healthy, Pharmacokinetics of ASP0456 | 32 | Jan 2011actual | — | 2011-01-20 |
| Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple SclerosisNCT00629642Change from baseline in maximum cystometric capacityRandomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: Solifenacin Succinate, Solifenacin Succinate, Oxybutynin Hydrochloride, Placebo | Multiple Sclerosis, Neurogenic Bladder, Spinal Cord Diseases | 249 | 2011-01-28actual | — | 2024-11-14 |
| Prevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous ThromboembolismNCT00937820Joint incidence of deep vein thromboembolism or pulmonary thromboembolismNon-randomized · Open-label · Prevention | Phase 3 | Completed | Drug: YM150 | Venous Thromboembolism | 87 | Dec 2010actual | — | 2011-01-06 |
| A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation PatientsNCT01018914Incidence of biopsy confirmed acute rejectionRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: Prograf, Advagraf, Myfortic | Liver Transplantation | 44 | Dec 2010actual | — | 2016-01-29 |
| A Study to Compare Two Medications With an Inactive Medication and Look at the Effect on a Person's Mental AbilityNCT01126424results2012-10-15Change From Baseline in Cognitive Function Composite Score - Power of AttentionRandomized · Quadruple-masked | Phase 4 | Completed | Drug: Solifenacin, Oxybutynin, Placebo | Cognition | 26 | Dec 2010actual | — | 2012-10-15 |
| A Study to Investigate the Effect of Food on the Absorption, Distribution and Elimination of ASP1941NCT01674777Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and CmaxRandomized · Open-label | Phase 1 | Completed | Drug: ASP1941 | Healthy, Pharmacokinetics of ASP1941 | 30 | Dec 2010actual | — | 2012-08-29 |
| A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia PatientsNCT00956319Total score of Pittsburgh Sleep Quality Index (PSQ)Randomized · Open-label · Treatment | Phase 4 | Completed | Drug: Zolpidem MR, Estazolam | Sleep Initiation and Maintenance Disorders, Primary Insomnia | 42 | Nov 2010actual | — | 2011-10-06 |
| A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain PatientsNCT01118572Patient impressions (4-categorical assessments)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: YM177, etodolac, Placebo | Post Operative Pain | 616 | Nov 2010actual | — | 2014-10-15 |
| A Study to Evaluate the Effect of Oral Mirabegron on the Heart in Healthy Males and FemalesNCT01199523QTcl evaluated through electrocardiogram analysisRandomized · Triple-masked | Phase 1 | Completed | Drug: Placebo, mirabegron, moxifloxacin | Healthy Subjects | 352 | Nov 2010actual | — | 2013-07-03 |
| A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes PatientsNCT01057628change from baseline in HbA1cRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ipragliflozin, placebo | Type 2 Diabetes Mellitus | 130 | 2010-11-06actual | — | 2025-05-30 |
| A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831NCT00668070ALTRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ASP9831, Placebo | Non-Alcoholic Steatohepatitis | 114 | Oct 2010actual | — | 2013-03-21 |
| A Study to Assess the Bioavailability of ASP015KNCT01430078Pharmacokinetic assessment of AUC through the analysis of blood samplesRandomized · Open-label | Phase 1 | Completed | Drug: ASP015K, ASP015K | Healthy | 12 | Oct 2010actual | — | 2011-09-07 |
| Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on HemodialysisNCT00892749Changes in serum Phosphorus levelOpen-label · Treatment | Phase 3 | Completed | Drug: ASP1585 | Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency, Hyperphosphatemia | 248 | Sep 2010actual | — | 2015-05-04 |
| A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial FibrillationNCT00938730Incidence of major and clinically relevant non-major bleeding eventsRandomized · Quadruple-masked · Prevention | Phase 2 | Completed | Drug: YM150, Warfarin | Atrial Fibrillation | 1,280 | Sep 2010actual | — | 2011-01-20 |
| A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal DialysisNCT01017276Serum phosphorus level at treatment discontinuationNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: ASP1585 | Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency | 35 | Sep 2010actual | — | 2015-05-04 |
| A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on HemodialysisNCT01057407Serum phosphorus level at the end of treatmentRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: ASP1585, Sevelamer hydrochloride | Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency | 110 | Sep 2010actual | — | 2015-05-04 |
| A Study to Evaluate the Drug Interaction of ASP015K and TacrolimusNCT01190670Pharmacokinetic variables assessment through analysis of blood and urine samplesRandomized · Open-label | Phase 1 | Completed | Drug: Tacrolimus, ASP015K | Healthy, Pharmacokinetics of ASP015K and Tacrolimus | 40 | Sep 2010actual | — | 2010-10-14 |
| Study of Intermittent OSI-906 DosingNCT00514306Determine the maximum tolerated dose (MTD) for each of 3 intermittent schedules and establish a recommended phase 2 dose of OSI-906Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: OSI-906 | Advanced Solid Tumors | 79 | 2010-09-20actual | — | 2024-11-20 |
| Reproducibility Study of Overactive Bladder Symptom Score [OABSS]NCT01122550observationalOABSS | — | Completed | — | Overactive Bladder | 50 | Aug 2010actual | — | 2010-08-24 |
| A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941NCT01187186Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samplesNon-randomized · Open-label | Phase 1 | Completed | Drug: ASP1941 | Liver Disease | 16 | Aug 2010actual | — | 2010-10-07 |
| A Study to Assess Drug Interaction of ASP015K and MidazolamNCT01182077Pharmacokinetic variables assessed through the analysis of blood and urine samplesRandomized · Open-label | Phase 1 | Completed | Drug: ASP015K, Midazolam | Healthy, Pharmacokinetics of ASP015K and Midazolam | 30 | Jul 2010actual | — | 2010-08-16 |
| Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)NCT00826280results2011-10-21Change in Number of Reversible DefectsRandomized · Quadruple-masked · Diagnostic | Phase 3 | Completed | Drug: regadenoson, overencapsulated caffeine, placebo · Radiation: technetium | Coronary Artery Disease (CAD) | 347 | 2010-07-15actual | — | 2024-12-03 |
| A Phase 1 Study of the Safety and Pharmacokinetics of AGS-8M4 in Subjects With Advanced Ovarian CancerNCT00816764Incidence of adverse eventsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Biological: AGS-8M4 | Carcinoma, Ovarian Cancer, Ovarian Diseases, Ovarian Neoplasms | 18 | Jun 2010actual | — | 2013-02-27 |
| Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male VolunteersNCT00978198Safety and tolerability of ASP1517Randomized · Single-masked | Phase 1 | Completed | Drug: ASP1517, Placebo | Healthy Volunteers | 100 | Jun 2010actual | — | 2010-06-22 |
| Renal Impairment Study With ASP1941NCT01302028Effect of grade of renal impairment on the pharmacokinetics of ASP1941Randomized · Open-label · Basic science | Phase 1 | Completed | Drug: ASP1941 | Type 2 Diabetes Mellitus | 40 | 2010-06-26actual | — | 2017-08-22 |
| A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal ImpairmentNCT01097681Plasma concentration of ASP1941Non-randomized · Open-label · Other | Phase 1 | Completed | Drug: ASP1941 | Type 2 Diabetes Mellitus | 25 | 2010-06-18actual | — | 2024-11-12 |
| ASP1517 Pharmacokinetics Study in Anemia Patients on HemodialysisNCT01083888ASP1517 concentrations in plasmaNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: roxadustat | Anemia, Hemodialysis, Renal Impairment | 12 | 2010-06-07actual | — | 2024-10-30 |
| A Study to Assess the Systemic Disposition of ASP1585 After Administration of 14C-labeled DrugNCT01124747Excretion of radioactivity in urineNon-randomized · Open-label | Phase 1 | Completed | Drug: ASP1585, 14C-Labeled ASP1585 | Healthy, Pharmacokinetics of ASP1585 | 12 | May 2010actual | — | 2014-05-05 |
| To Evaluate Whether Naproxen and Darexaban (YM150) Interact in Their EffectsNCT01409603Assessment of pharmacodynamics of naproxenRandomized · Open-label | Phase 1 | Completed | Drug: darexaban, Naproxen | Pharmacodynamic Interaction, Healthy Subjects | 26 | May 2010actual | — | 2013-04-11 |
| Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive BladderNCT00688688results2012-10-19Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Mirabegron, Tolterodine, Placebo to Mirabegron, Placebo to Tolterodine | Urinary Bladder, Overactive | 2,792 | 2010-05-06actual | — | 2024-11-20 |
| Phase I Study of OSI-930 and Erlotinib in Cancer TumorsNCT00603356Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profilesNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: OSI-930 and erlotinib | Advanced Solid Tumors | 60 | Apr 2010actual | — | 2011-09-27 |
| A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Kidney Transplant RecipientsNCT00717678The patient and graft survival rates at 6 month post-transplantRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Prograf-XL, Prograf, MMF | Kidney Transplantation, Transplantation Immunology, Host vs Graft Reaction | 73 | Apr 2010actual | — | 2015-12-17 |
| ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis PatientsNCT00794443Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA methodRandomized · Quadruple-masked · Treatment | Phase 2/3 | Completed | Drug: YM529 / ONO-5920 | Osteoporosis, Bone Loss, Age-Related | 692 | Apr 2010actual | — | 2015-05-04 |
| A Phase 1 Study of the Safety and Pharmacokinetics of AGS-16M18 in Subjects With Advanced Renal Cell CancerNCT00816686Incidence of adverse eventsNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Trial was terminated due to the need to re-formulate the study drug. | Biological: AGS-16M18 | Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases | 7 | Apr 2010actual | — | 2013-02-27 |
| Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy VolunteersNCT00870441Assessment of clinical laboratory evaluations and adverse eventsRandomized · Quadruple-masked | Phase 1 | Terminatedsponsor's stated reason: Study terminated due to treatment-emergent serious adverse events | Drug: ASP2151, Valacyclovir, Placebo | Safety of ASP2151 | 442 | Apr 2010actual | — | 2013-02-28 |
| Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower ExtremitiesNCT00937911Incidence of venous thromboembolismNon-randomized · Open-label · Prevention | Phase 3 | Completed | Drug: YM150 | Venous Thromboembolism | 101 | Apr 2010actual | — | 2010-06-16 |
| A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal SurgeryNCT00942435Composite assessment of venous thromboembolism events and all causes of deathRandomized · Open-label · Prevention | Phase 3 | Completed | Drug: YM150 · Procedure: mechanical prophylaxis | Venous Thromboembolism | 156 | Apr 2010actual | — | 2010-06-16 |
| A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian CancerNCT01016054Incidence of adverse eventsNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Trial was terminated to allow sponsors to evaluate the future development of the drug program | Biological: AGS-8M4 · Drug: Pegylated liposomal doxorubicin (PLD), gemcitabine, carboplatin | Carcinoma, Ovarian Cancer, Ovarian Diseases, Ovarian Neoplasms | 4 | Apr 2010actual | — | 2013-02-27 |
| YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical IllnessNCT01028950Composite assessment of VTE events and all cause deathOpen-label · Prevention | Phase 3 | Completed | Drug: YM150 | Venous Thromboembolism | 52 | Apr 2010actual | — | 2010-06-16 |
| A Study to Assess Drug-Drug Interaction Between ASP1941 and MiglitolNCT01099839Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samplesRandomized · Open-label | Phase 1 | Completed | Drug: ASP1941, Miglitol | Healthy Volunteers, Pharmacokinetics of ASP1941 | 30 | Apr 2010actual | — | 2010-06-09 |
| A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy VolunteersNCT01115946Plasma concentration of enalaprilRandomized · Open-label | Phase 1 | Completed | Drug: ASP1585, enalapril | Healthy, Pharmacokinetics of Enalapril | 24 | Apr 2010actual | — | 2010-05-27 |
| A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Valsartan in Healthy VolunteersNCT01115972Plasma concentration of valsartanRandomized · Open-label | Phase 1 | Completed | Drug: ASP1585, valsartan | Healthy, Pharmacokinetics of Valsartan | 24 | Apr 2010actual | — | 2010-05-27 |
| A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Atorvastatin in Healthy VolunteersNCT01115985Plasma concentration of atorvastatinRandomized · Open-label | Phase 1 | Completed | Drug: ASP1585, atorvastatin | Healthy, Pharmacokinetics of Atorvastatin | 24 | Apr 2010actual | — | 2010-05-27 |
| A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 TabletNCT01125670Plasma concentration of YM150 and its metabolites measured by blood samplesRandomized · Open-label | Phase 1 | Completed | Drug: YM150 | Healthy Volunteer, Pharmacokinetics of YM150 | 24 | Apr 2010actual | — | 2010-05-25 |
| Drug-drug Interaction Study With ASP1941 and GlimepirideNCT01302158Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepirideRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: ASP1941, Glimepiride | Healthy Subjects | 52 | Apr 2010actual | — | 2011-02-23 |
| A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive BladderNCT00912964results2012-10-17Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 HoursRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Mirabegron, Placebo | Urinary Bladder, Overactive | 2,030 | 2010-04-27actual | — | 2024-11-21 |
| An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid TumorsNCT00514267Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC)Non-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: YM 155, Docetaxel, Prednisone | Prostate Cancer, Tumors | 32 | Mar 2010actual | — | 2015-08-13 |
| Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With PolysomnographyNCT00653562Sleep latencyNon-randomized · Single-masked · Treatment | Phase 4 | Completed | Drug: zolpidem | Insomnia, Sleep Initiation and Maintenance Disorders | 11 | Mar 2010actual | — | 2017-02-17 |
| A Long-term Study of YM178 in Symptomatic Overactive Bladder PatientsNCT00840645Vital signs, AEs, lab tests, ECG, post-void residual volumeNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: YM178 | Urinary Bladder, Overactive | 204 | Mar 2010actual | — | 2016-01-05 |
| Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release TacrolimusNCT00909571Assessment of pharmacokinetic parametersRandomized · Open-label | Phase 3 | Completed | Drug: FK506E (modified release tacrolimus), Prograf (tacrolimus) | Liver Transplantation | 10 | Mar 2010actual | — | 2010-04-16 |
| Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement SurgeryNCT00913120Overall incidence of venous thromboembolismRandomized · Quadruple-masked · Prevention | Phase 2/3 | Completed | Drug: YM150, Placebo, Enoxaparin | Venous Thromboembolism | 610 | Mar 2010actual | — | 2010-06-09 |
| A Clinical Pharmacological Study of YM155 After Intravenous Infusion in Patients With Advanced CancerNCT01023386To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusionNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: YM155 | Cancer | 6 | Mar 2010actual | — | 2010-04-13 |
| A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Sitagliptin When Given Together to Healthy SubjectsNCT01104532Pharmacokinetic variables assessment through analysis of blood samplesRandomized · Open-label | Phase 1 | Completed | Drug: ASP1941, sitagliptin | Healthy, Pharmacokinetics of ASP1941 | 64 | Mar 2010actual | — | 2010-04-16 |
| A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-BNCT01125657Plasma concentration of YM150 and its metabolites measured by blood sampleRandomized · Open-label | Phase 1 | Completed | Drug: YM150 | Healthy Volunteer, Pharmacokinetics of YM150 | 44 | Mar 2010actual | — | 2010-05-25 |
| To Evaluate if Multiple Doses of Ketoconazole Change the Blood Concentration of YM150 (Darexaban)NCT01405989Pharmacokinetics of darexaban and its metabolites assessed by plasma concentrationRandomized · Open-label | Phase 1 | Completed | Drug: darexaban, ketoconazole | Pharmacokinetics of Darexaban and Metabolites, Healthy Subjects | 26 | Mar 2010actual | — | 2014-03-05 |
| To Evaluate if Multiple Doses of Rifampicin Change the Blood Concentration of YM150 (Darexaban)NCT01406002Pharmacokinetics of darexaban and its metabolites assessed by plasma concentrationOpen-label | Phase 1 | Completed | Drug: darexaban, Rifampicin | Pharmacokinetics of Darexaban and Metabolites, Healthy Subjects | 26 | Mar 2010actual | — | 2013-04-11 |
| Study to Evaluate Safety and Tolerability of FK949E in Patients With Major Depressive DisorderNCT01871974Maximum plasma concentration (Cmax) of unchanged quetiapineNon-randomized · Open-label · Other | Phase 1 | Completed | Drug: FK949E | Major Depressive Disorder Patients | 16 | Mar 2010actual | — | 2017-02-16 |
| A Study of ASP1941 in Japanese Patients With Type 2 Diabetes MellitusNCT01023945Change in plasma glucose levelsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: ASP1941, Placebo | Type 2 Diabetes Mellitus | 30 | 2010-03-26actual | — | 2024-11-12 |
| A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid ArthritisNCT01754805Pharmacokinetics of methotrexate (MTX): Area under the concentration-time curve from time of dosing to infinity (AUCinf)Open-label · Other | Phase 1 | Completed | Drug: peficitinib, methotrexate | Rheumatoid Arthritis | 15 | 2010-03-25actual | — | 2024-10-21 |
| Single and Multiple Oral Administration Study of ASP015K in Healthy Nonelderly VolunteersNCT01225224Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory testsRandomized · Quadruple-masked · Other | Phase 1 | Completed | Drug: peficitinib, Placebo | Pharmacokinetics of ASP015K, Healthy Volunteer | 72 | 2010-03-10actual | — | 2024-10-16 |
| A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney RejectionNCT00717470Efficacy failure rateRandomized · Open-label · Prevention | Phase 4 | Completed | Drug: Prograf®, Advagraf®, Mycophenolate Mofetil, Simulect, methylprednisolone / prednisone | Kidney Transplantation | 1,252 | 2010-03-02actual | — | 2024-11-01 |
| A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive BladderNCT00966004Change from baseline in the mean number of micturitions per 24 hoursRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: YM178, Placebo, tolterodine | Urinary Bladder, Overactive | 1,139 | 2010-02-15actual | — | 2024-10-31 |
| Zolpidem Postmarketing Study in Adolescent Patients With InsomniaNCT00432198Mean daily sleep latency for double-blind periodRandomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: Zolpidem (Myslee®), placebo | Insomnia | 122 | Jan 2010actual | — | 2017-02-17 |
| Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic HyperplasiaNCT00771394Change from baseline in mean number of urgency episodes per 24 hoursRandomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: Tamsulosin hydrochloride, Solifenacin succinate | Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Overactive Bladder | 638 | Jan 2010actual | — | 2013-02-15 |
| Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement SurgeryNCT00917254Overall incidence of venous thromboembolismRandomized · Quadruple-masked · Prevention | Phase 2/3 | Completed | Drug: YM150, Placebo, Enoxaparin | Venous Thromboembolism | 369 | Jan 2010actual | — | 2010-06-16 |
| A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150NCT01118559Plasma concentration of YM150 and its metabolitesRandomized · Open-label | Phase 1 | Completed | Drug: YM150 | Healthy, Pharmacokinetics of YM150 | 24 | Jan 2010actual | — | 2010-05-06 |
| A Study to Assess the Pharmacokinetics of ASP015K in Healthy Male SubjectsNCT01406132Pharmacokinetic assessment through radiographic and high performance liquid chromatography (HPLC) analysis of blood, urine and feces samplesNon-randomized · Open-label | Phase 1 | Completed | Drug: ASP015K | Healthy Subjects, Pharmacokinetics of ASP015K | 6 | Jan 2010actual | — | 2011-08-01 |
| Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute WardNCT00418873Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.Randomized · Open-label · Treatment | Phase 4 | Terminatedsponsor's stated reason: Study was stopped due to difficulty in patient enrollment | Drug: Zotepine, Risperidone | Schizophrenia | 39 | Dec 2009actual | — | 2010-04-16 |
| Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis SubjectsNCT00658606results2011-04-22Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16Randomized · Open-label · Treatment | Phase 4 | Completed | Drug: alefacept · Procedure: Narrow Band UVB Phototherapy | Plaque Psoriasis | 98 | Dec 2009actual | — | 2013-01-08 |
| A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional DyspepsiaNCT00764374Subject's global assessmentNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: YM443 | Dyspepsia, Functional Dyspepsia | 412 | Dec 2009actual | — | 2014-10-29 |
| Retrospective, Non-interventional Study of Depo-Eligard®.NCT00811876observationalTolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard® | — | Completed | Other: Data Collection on Depo-Eligard exposure | Prostate Cancer | 140 | Dec 2009actual | — | 2010-01-22 |
| A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal ImpairmentNCT00863707results2011-01-31Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)Randomized · Double-masked · Diagnostic | Phase 4 | Completed | Drug: Regadenoson, Placebo | Kidney Diseases, Coronary Artery Disease | 511 | Dec 2009actual | — | 2012-05-18 |
| A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel SyndromeNCT00918411IBS severity index (Japanese version)Randomized · Single-masked | Phase 4 | Completed | Drug: Ramosetron, Placebo | Irritable Bowel Syndrome | 98 | Dec 2009actual | — | 2015-10-12 |
| A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Pioglitazone Hydrochloride When Given Together to Healthy SubjectsNCT01088919Pharmacokinetic variables assessment through analysis of blood samplesRandomized · Open-label | Phase 1 | Completed | Drug: ASP1941, pioglitazone hydrochloride | Healthy, Pharmacokinetics of ASP1941 | 64 | Dec 2009actual | — | 2010-04-16 |
| Drug to Drug Interaction Study With ASP1941 and MetforminNCT01302145Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoringRandomized · Double-masked · Basic science | Phase 1 | Completed | Drug: ASP1941, Metformin, Placebo | Type 2 Diabetes Mellitus | 36 | 2009-12-09actual | — | 2017-07-28 |
| Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)NCT00285259Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCTRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Biological: VCL-CB01 · Other: Phosphate-buffered Saline (PBS) | Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Myelodysplastic Syndrome | 112 | 2009-11-30actual | — | 2024-10-21 |
| A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal InfectionsNCT00794703Treatment success rate (fungal breakthrough rate)Randomized · Open-label · Prevention | Phase 3 | Completed | Drug: micafungin (Mycamine), itraconazole | Fungemia, Fungal Infections | 288 | Nov 2009actual | — | 2016-03-28 |
| Relative Bioavailability Study of Solifenacin Succinate Liquid Suspension (Fed and Fasting) Versus VESIcare Tablet (Fasting) in Healthy VolunteersNCT01015040Serum solifenacin succinate pharmacokinetics (PK) parametersRandomized · Open-label | Phase 1 | Completed | Drug: solifenacin succinate suspension, solifenacin succinate tablet | Bioavailability of Solifenacin Succinate, Pharmacokinetics of Solifenacin Succinate, Healthy Volunteers | 24 | Nov 2009actual | — | 2009-12-07 |
| A Study in Healthy Young Men to Look at What Drives the Cardiovascular Effects After Dosing With Mirabegron.NCT01284868Plasma renin activityRandomized · Single-masked · Basic science | Phase 1 | Completed | Drug: mirabegron, Bisoprolol, propranolol, placebo | Healthy Volunteers, Pharmacodynamics of Mirabegron | 12 | Nov 2009actual | — | 2013-07-03 |
| A Study to Evaluate How Mirabegron Enters and Leaves the Bloodstream According to Age and SexNCT01285596Assessment of pharmacokinetics of mirabegron and its metabolitesRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: Mirabegron | Healthy Volunteers, Pharmacokinetics of Mirabegron | 75 | Nov 2009actual | — | 2013-07-03 |
| Phase II Study of ASP3550 in Patients With Prostate CancerNCT00568516Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatmentRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: ASP3550 | Prostatic Neoplasms | 273 | Oct 2009actual | — | 2014-10-29 |
| Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the DrugNCT00607763Evaluation of Micafungin pharmacokineticsNon-randomized · Open-label | Phase 1 | Completed | Drug: Micafungin (Mycamine) | Invasive Candidiasis, Esophageal Candidiasis, Oropharyngeal Candidiasis, Candidemia | 9 | Oct 2009actual | — | 2014-08-20 |
| A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary DiseaseNCT00862641results2010-12-15Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline AssessmentRandomized · Double-masked · Diagnostic | Phase 4 | Completed | Drug: Regadenoson, Placebo | Asthma, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive | 1,009 | Oct 2009actual | — | 2012-09-18 |
| AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate CancerNCT00519233Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: AGS-1C4D4 | Prostate Cancer | 13 | Sep 2009actual | — | 2014-05-02 |
| A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant RecipientsNCT00617604results2016-02-04Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local ReviewRandomized · Quadruple-masked · Prevention | Phase 2 | Completed | Drug: Alefacept, placebo, Tacrolimus, Mycophenolate Mofetil, Steroids | De Novo Kidney Transplantation | 218 | Sep 2009actual | — | 2016-02-04 |
| A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.NCT00720408Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 6 months post-transplant.Randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Prograf-XL, Prograf, MMF | Liver Transplantation, Transplantation Immunology, Host vs Graft Reaction | 48 | Sep 2009actual | — | 2009-09-15 |
| A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal ImpairmentNCT00750620Assessment of pharmacokinetics parametersNon-randomized · Open-label | Phase 1 | Completed | Drug: YM178 | Renal Impairment | 33 | Sep 2009actual | — | 2013-09-05 |
| A Study to Investigate the Food Effect on the Pharmacokinetics of YM178 in Healthy, Non-elderly VolunteersNCT00965926Plasma concentration of unchanged YM178Randomized · Open-label | Phase 1 | Completed | Drug: YM178 | Healthy Volunteer, Pharmacokinetics of YM178 | 72 | Sep 2009actual | — | 2013-07-17 |
| A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent FormulationNCT00965978Pharmacokinetic parameter of ONO-5920/YM529Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ONO-5920 / YM529 | Osteoporosis, Osteoporosis, Postmenopausal, Bone Diseases | 48 | Sep 2009actual | — | 2009-10-05 |
| To Evaluate Whether Acetyl Salicylic Acid (Aspirin), the Combination of Aspirin and Clopidogrel and Darexaban (YM150) Interact in Their EffectsNCT01409616Assessment of pharmacodynamics of darexabanRandomized · Open-label | Phase 1 | Completed | Drug: darexaban, darexaban (double dose), Acetyl Salicylic Acid, clopidogrel | Pharmacodynamic Interaction, Healthy Subjects | 100 | Sep 2009actual | — | 2013-03-21 |
| A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to MethotrexateNCT01224418ACR20 response rate compared to baselineOpen-label · Treatment | Phase 4 | Completed | Drug: Tacrolimus | Rheumatoid Arthritis | 50 | Aug 2009actual | — | 2010-10-20 |
| Study to Evaluate the Effect of Food Intake on the Plasma Concentration Changes of Quetiapine After Oral Administration of FK949E in Healthy VolunteersNCT01871987Maximum plasma concentration (Cmax) of unchanged quetiapineNon-randomized · Open-label · Other | Phase 1 | Completed | Drug: FK949E | Healthy, Plasma Concentration Change of Quetiapine | 24 | Aug 2009actual | — | 2017-03-09 |
| Phase 1 Study of OSI-930 in Cancer PatientsNCT00513851Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of OSI-930Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: OSI-930, OSI-930 | Advanced Solid Tumors | 60 | Jul 2009actual | — | 2011-09-27 |
| Study of the Effect of Food on the Pharmacokinetics of MirabegronNCT00939757Assess the effects of food on the pharmacokinetics of a single oral dose of mirabegronRandomized · Open-label | Phase 1 | Completed | Drug: mirabegron | Healthy, Pharmacokinetics of Mirabegron | 76 | Jul 2009actual | — | 2013-06-26 |
| A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin SimultaneouslyNCT01297192Assessment of pharmacokinetics of solifenacin through analysis of blood samplesNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: solifenacin succinate, mirabegron | Healthy Volunteers, Pharmacokinetics of Mirabegron | 41 | Jul 2009actual | — | 2013-07-29 |
| Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) MirabegronNCT00940121Characterize the pharmacokinetic profile of 3 doses of oral mirabegron formulations with three different release rates vs. three doses of mirabegron administered intravenouslyRandomized · Open-label · Other | Phase 1 | Completed | Drug: mirabegron, mirabegron | Healthy, Pharmacokinetics of Mirabegron | 91 | 2009-07-13actual | — | 2024-10-16 |
| Safety, Tolerability and Efficacy Study of the New Medication ASK8007 to Treat Patients With Rheumatoid ArthritisNCT00411424Safety and tolerability MD ASK8007Randomized · Quadruple-masked · Treatment | Phase 1/2 | Completed | Drug: ASK8007, Placebo | Rheumatoid Arthritis | 54 | Jun 2009actual | — | 2013-03-21 |
| Effect of Food Intake on Pharmacokinetic Profiles of Z-338NCT00920998Pharmacokinetics of Z-338Randomized · Open-label | Phase 1 | Completed | Drug: Z-338 | Healthy | 30 | Jun 2009actual | — | 2009-07-20 |
| Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy VolunteersNCT01364987Assessment of pharmacokinetic variables through analysis of blood and urine samplesOpen-label | Phase 1 | Completed | Drug: ASP015K, Mycophenolate Mofetil | Healthy Subjects, Drug Interactions, Pharmacokinetics of ASP015K | 24 | Jun 2009actual | — | 2011-06-03 |
| Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Tacrolimus in Healthy VolunteersNCT01430065Pharmacokinetic assessment of AUC through the analysis of blood and urine samplesNon-randomized · Open-label | Phase 1 | Completed | Drug: ASP015K, Tacrolimus | Pharmacokinetics of ASP015K, Drug Interactions, Healthy Subjects | 24 | Jun 2009actual | — | 2011-09-07 |
| A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement SurgeryNCT00595426The incidence of total venous thromboembolisms (VTE).Randomized · Double-masked · Prevention | Phase 2 | Completed | Drug: YM150, Warfarin | Arthroplasty, Replacement, Knee | 685 | May 2009actual | — | 2013-03-25 |
| Reproducibility Study of Over Active Bladder Symptom Score [OABSS]NCT00901251observationalOABSS | — | Completed | — | Overactive Bladder | 50 | May 2009actual | — | 2011-03-15 |
| A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015KNCT01364974Safety and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samplesRandomized · Quadruple-masked | Phase 1 | Completed | Drug: ASP015K, Placebo | Healthy Subjects, Pharmacokinetics of ASP015K, Pharmacodynamics | 48 | May 2009actual | — | 2011-06-03 |
| Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant SubjectsNCT00481481Change in creatinine clearance, calculated according to Cockcroft and Gault formula.Non-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: tacrolimus | Transplantation | 346 | Apr 2009actual | — | 2014-07-18 |
| Study of YM155 in Refractory Diffuse Large B-cell Lymphoma (DLBCL) SubjectsNCT00498914Overall response rateNon-randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Futility boundary at interim analysis not met | Drug: YM155 | Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell Refractory | 41 | Apr 2009actual | — | 2015-09-04 |
| A Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy AdultsNCT00850746Mean change in the QTcF (Fridericia's correction) between each active treatment and placeboRandomized · Quadruple-masked | Phase 1 | Completed | Drug: YM443, Placebo, Moxifloxacin | Functional Dyspepsia | 80 | Apr 2009actual | — | 2014-03-24 |
| Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome PatientsNCT02658188Change from baseline in IRLS scoreOpen-label · Treatment | Phase 3 | Completed | Drug: ASP8825 | Restless Legs Syndrome | 182 | Apr 2009actual | — | 2016-02-04 |
| A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive BladderNCT00662909results2012-10-17Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 HoursRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Mirabegron, Placebo | Urinary Bladder, Overactive | 2,149 | 2009-04-22actual | — | 2024-11-20 |
| Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant RecipientsNCT00113269results2011-07-08Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 MonthsRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: basiliximab, rabbit anti-thymocyte globulin, tacrolimus, alemtuzumab, mycophenolate mofetil, steroids | Kidney Transplantation | 501 | Mar 2009actual | — | 2011-08-11 |
| Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee ReplacementNCT00408239All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatmentRandomized · Open-label · Prevention | Phase 2 | Completed | Drug: YM150, enoxaparin | Thromboembolism | 367 | Mar 2009actual | — | 2011-12-19 |
| A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver TransplantationNCT00459719Event rate of patients with acute rejectionsRandomized · Open-label · Prevention | Phase 3 | Completed | Drug: Tacrolimus modified-release, Prograf | Liver Transplantation | 42 | Mar 2009actual | — | 2016-02-24 |
| A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney TransplantationNCT00481819Event rate of patients with acute rejectionsRandomized · Open-label · Prevention | Phase 3 | Completed | Drug: FK506MR, Prograf, Mycophenolate Mofetil, Methylprednisolone, Prednisolone | Kidney Transplantation | 240 | Mar 2009actual | — | 2016-02-24 |
| A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell TransplantNCT00606268Plasma drug concentration parameters: AUC0-24, CmaxNon-randomized · Open-label · Prevention | Phase 1 | Completed | Drug: Micafungin | Fungal Infections | 42 | Mar 2009actual | — | 2014-08-21 |
| A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation PatientsNCT00619398Event rate of patients with acute rejectionsRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Prograf, FK506MR capsule | Liver Transplantation | 172 | Mar 2009actual | — | 2016-02-24 |
| A Study to Evaluate the Possible Effects of Taking Mirabegron While Taking a Contraceptive PillNCT01297179Assessment of pharmacokinetics of Ethinyl estradiol (EE) and Levonorgestrel (LNG) by analysis of blood samples.Randomized · Triple-masked · Basic science | Phase 1 | Completed | Drug: Mirabegron, Minidril, Placebo | Healthy Volunteers, Pharmacokinetics of Mirabegron | 30 | Mar 2009actual | — | 2013-07-03 |
| Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive BladderNCT00689104results2012-10-17Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 HoursRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Mirabegron, Tolterodine, Placebo to Mirabegron, Placebo to Tolterodine | Urinary Bladder, Overactive | 2,336 | 2009-03-24actual | — | 2024-11-20 |
| A Study of ASP1941 in Participants With Type 2 Diabetes MellitusNCT00621868HbA1c levelRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ipragliflozin, Placebo | Diabetes Mellitus | 361 | 2009-03-14actual | — | 2024-11-12 |
| A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.NCT00790660Evaluation of safety through clinical safety labs and adverse eventsRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: ASP1941, Placebo | Diabetes Mellitus, Type 2 | 61 | 2009-03-06actual | — | 2024-11-14 |
| An Open Study for Steroid Resistant, Non-Thymectomized MG PatientsNCT00309101Improvement of clinical symptomsNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: tacrolimus | Myasthenia Gravis | 11 | Feb 2009actual | — | 2009-06-03 |
| ASP8825 - A Study to Investigate the Food Effect on the Pharmacokinetics of ASP8825NCT02632331Pharmacokinetics (PK) parameter of gabapentin: CmaxRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: ASP8825 | Healthy Volunteers | 18 | Feb 2009actual | — | 2015-12-16 |
| ASP8825 - Study in Patients With Restless Legs SyndromeNCT00530530The change of the International Restless Legs Syndrome rating scale scoreRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ASP8825, Placebo | Restless Legs Syndrome | 474 | Jan 2009actual | — | 2014-10-29 |
| To Evaluate the Effect of Mirabegron (YM178) on Blood Levels of Desipramine When They Are Taken TogetherNCT01478568Pharmacokinetics of desipramine assessed by plasma concentration while at steady state levels of mirabegronOpen-label | Phase 1 | Completed | Drug: mirabegron, desipramine | Pharmacokinetics of Mirabegron, Healthy Subjects | 28 | Jan 2009actual | — | 2014-04-10 |
| Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy VolunteersNCT00776516Assess pharmacokinetics of mirabegron alone and in combination with rifampinNon-randomized · Open-label | Phase 1 | Completed | Drug: mirabegron, rifampin | Pharmacokinetics of YM178 | 24 | Dec 2008actual | — | 2013-07-03 |
| A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy SubjectsNCT00856570R- and S-warfarin in plasma: AUCinf, AUClast, Cmax, tmax, t1/2, CL/FNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: warfarin, YM178 | Overactive Bladder, Pharmacokinetics | 24 | Dec 2008actual | — | 2013-07-02 |
| ASP 8825 - Study in Patients With Painful Diabetic PolyneuropathyNCT00508430Pain severity ratingRandomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: An independent DMC determined continuation was unlikely to demonstrate a statistically significant advantage of ASP8825 over placebo on the primary endpoint | Drug: ASP8825, Placebo | Diabetic Neuropathies | 199 | Nov 2008actual | — | 2008-12-05 |
| A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015KNCT01387087Safety and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samplesRandomized · Quadruple-masked | Phase 1 | Completed | Drug: ASP015K, Placebo | Healthy Subjects, Pharmacokinetics of ASP015K | 72 | Nov 2008actual | — | 2011-07-04 |
| A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant PatientsNCT00282243results2013-09-30Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for TacrolimusNon-randomized · Open-label · Prevention | Phase 2 | Completed | Drug: tacrolimus modified release (MR), tacrolimus | Liver Transplantation | 70 | Oct 2008actual | — | 2013-09-30 |
| A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant PatientsNCT00282256results2013-10-17Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for TacrolimusNon-randomized · Open-label · Prevention | Phase 2 | Completed | Drug: tacrolimus modified release (MR), tacrolimus | Liver Transplantation | 19 | Oct 2008actual | — | 2013-10-17 |
| A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant PatientsNCT00282568results2013-09-26Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for TacrolimusNon-randomized · Open-label · Prevention | Phase 2 | Completed | Drug: Tacrolimus Modified Release (MR), tacrolimus | Kidney Transplantation | 70 | Oct 2008actual | — | 2013-09-26 |
| A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA PatientsNCT00319917Radiographic progression of structural joint damageRandomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: tacrolimus, placebo | Rheumatoid Arthritis | 123 | Oct 2008actual | — | 2014-08-21 |
| Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial FibrillationNCT00448214All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"Randomized · Quadruple-masked · Prevention | Phase 2 | Completed | Drug: YM150, warfarin | Atrial Fibrillation | 448 | Oct 2008actual | — | 2011-12-19 |
| Study of Tacrolimus Immunosuppressive Therapy After Kidney TransplantationNCT00717379Incidence and time to first biopsy-proven acute rejectionRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: Tacrolimus, Mycophenolate Mofetil, Methylprednisolone or equivalent, Prednisone | Kidney Transplantation, Kidney Failure, Chronic, Renal Insufficiency, Chronic | 50 | Oct 2008actual | — | 2009-04-15 |
| Mass Balance Study of ASP1941NCT01302132Pharmacokinetics of ASP1941 to evaluate metabolism and excretionOpen-label | Phase 1 | Completed | Drug: ASP1941 | Healthy Subjects | 6 | Oct 2008actual | — | 2011-02-23 |
| ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and HaemodialysisNCT02629224Pharmacokinetics (PK) parameter of gabapentin in plasma: Cmax in Renal impairment patientsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ASP8825 | Patients With Impaired Renal Function and Haemodialysis | 18 | Oct 2008actual | — | 2016-02-04 |
| Micafungin Salvage Mono-therapy in Invasive AspergillosisNCT00376337Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response.Randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Study was stopped due to difficulties in recruitment and changes in standard care for invasive aspergillosis | Drug: Micafungin, Systemic antifungal therapy | Invasive Aspergillosis | 17 | Sep 2008actual | — | 2013-09-05 |
| A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on HemodialysisNCT00505037Change in serum phosphorusRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ASP1585, Placebo, Sevelamer hydrochloride | Hyperphosphatemia, Chronic Kidney Disease | 156 | Sep 2008actual | — | 2011-03-22 |
| Drug-Drug Interaction Study of TRK-100STPNCT00719758Pharmacokinetic profileRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: TRK-100STP (BERASUS LA), AST-120 (Kremezin®) | Healthy | 24 | Sep 2008actual | — | 2008-10-13 |
| Comparison of Extended Release Tacrolimus (Advagraf) and Cyclosporine A Microemulsion on Renal Function in Healthy VolunteersNCT00818194Comparison of Effective Renal Plasma Flow responseRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: extended release tacrolimus, cyclosporine A microemulsion | Healthy | 18 | Sep 2008actual | — | 2014-07-09 |
| Dose-finding Study of ASP2151 in Subjects With Herpes ZosterNCT00487682To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes ZosterRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ASP2151, Valacyclovir hydrochloride | Herpes Zoster | 403 | 2008-09-01actual | — | 2018-11-23 |
| A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)NCT00410514results2012-09-05Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: Mirabegron, Placebo | Lower Urinary Tract Symptoms, Bladder Outlet Obstruction | 200 | Aug 2008actual | — | 2014-04-04 |
| Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet ObstructionNCT00507455results2014-08-06Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: solifenacin succinate, tamsulosin hydrochloride, Placebo to solifenacin, Placebo to tamsulosin | Lower Urinary Tract Symptoms, Bladder Outlet Obstruction | 222 | Aug 2008actual | — | 2014-08-06 |
| A Study With ASP2151 in Subjects With Recurrent Episodes of Genital HerpesNCT00486200To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus InfectionRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ASP2151, valacyclovir, Placebo | Herpes Genitalis | 695 | 2008-08-12actual | — | 2017-12-07 |
| Study to Evaluate the Immune Response to Pneumococcal Vaccine in Alefacept-treated Adults With Chronic Plaque PsoriasisNCT00493324The number and percentage of subjects with at least a 2-fold increase in 2 or more of 5 pneumococcal antibody titers.Non-randomized · Open-label · Prevention | Phase 4 | Completed | Drug: alefacept, polyvalent pneumococcal vaccine | Chronic Plaque Psoriasis | 43 | Jul 2008actual | — | 2012-02-02 |
| Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of LifeNCT00573508results2010-10-05Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother ScoreRandomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: Placebo, Solifenacin Succinate | Urinary Bladder, Overactive | 768 | Jul 2008actual | — | 2010-10-05 |
| A Study of Pharmacokinetics and Safety of Alefacept in Caucasian and Japanese Healthy VolunteersNCT00653822Serum alefacept pharmacokinetic parametersRandomized · Quadruple-masked | Phase 1 | Completed | Drug: alefacept, placebo | Pharmacokinetics of Alefacept | 75 | Jul 2008actual | — | 2013-02-28 |
| Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic RegimensNCT00157014results2011-02-21The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial BiopsiesRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Tacrolimus, Cyclosporine, Mycophenolate mofetil, Methylprednisolone, Prednisone | Heart Diseases, Heart Transplantation | 111 | 2008-07-18actual | — | 2017-06-05 |
| Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant PatientsNCT00295607Viral load of HCV at 12 months post transplantationRandomized · Open-label · Prevention | Phase 2 | Completed | Drug: Tacrolimus, steroids, monoclonal anti-IL2R antibody | Hepatitis C, Liver Transplantation | 138 | Jun 2008actual | — | 2013-04-11 |
| FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) PatientsNCT00309088Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.]Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: tacrolimus, placebo | Myasthenia Gravis | 80 | Jun 2008actual | — | 2014-08-25 |
| A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus SubjectsNCT00454233Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: YM543, Metformin, Placebo | Diabetes Mellitus Type 2 | 97 | Jun 2008actual | — | 2008-10-16 |
| A Study to Assess the Safety and Efficacy of Prograf and MR4 in Liver Transplant RecipientsNCT00719745Event rate of patients with biopsy-proven acute rejectionsRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Prograf, MR4 | Liver Transplantation | 74 | Jun 2008actual | — | 2008-07-22 |
| Dose Range-finding Study of ASP1585 in Chronic Kidney Disease Patients on Hemodialysis With HyperphosphatemiaNCT02753894Change from the baseline of serum phosphorus levelRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: ASP1585 | Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia | 73 | Jun 2008actual | — | 2016-06-21 |
| Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) ProgramNCT00371774observationalUnderstand how AMEVIVE is used in routine clinical practice/real world setting | — | Completed | — | Plaque Psoriasis | 426 | May 2008actual | — | 2011-11-17 |
| A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia PatientsNCT00374777Mean wake time after sleep onset during the double-blind periodRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: zolpidem MR, nitrazepam, placebo | Sleep Initiation and Maintenance Disorders | 450 | May 2008actual | — | 2014-08-20 |
| Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis PatientsNCT00643071Improvement of Disease Activity Index score (DAI score)Non-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Tacrolimus | Ulcerative Colitis | 32 | May 2008actual | — | 2014-08-26 |
| A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical ProstatectomyNCT00106392results2010-10-28Erectile Function Domain Score Between Treated and Untreated GroupsRandomized · Quadruple-masked · Prevention | Phase 4 | Completed | Drug: Tacrolimus, Placebo | Erectile Dysfunction, Prostate Cancer | 131 | Apr 2008actual | — | 2010-11-23 |
| Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis PatientsNCT00347048Improvement of Disease activity index score (DAI score)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: tacrolimus, Placebo | Ulcerative Colitis | 62 | Apr 2008actual | — | 2014-08-26 |
| A Study of YM178 in Patients With Symptomatic Overactive BladderNCT00527033Overactive bladder symptomsRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: YM178, Placebo | Urinary Bladder, Overactive | 842 | 2008-04-03actual | — | 2024-10-31 |
| Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor KidneysNCT00321113Calculated creatinine clearanceRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: tacrolimus, mycophenolate mofetil, steroids | KIDNEY TRANSPLANTATION | 142 | Mar 2008actual | — | 2017-02-24 |
| A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder PatientsNCT00368706Change from baseline in mean number of micturitions per 24 hoursRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: solifenacin succinate, tolterodine | Urinary Bladder, Overactive | 246 | Mar 2008actual | — | 2008-04-10 |
| A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation PatientsNCT00720265Acute rejection within 24 weeks (6 months)Randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Prograf, MR4 | Kidney Transplantation | 135 | Mar 2008actual | — | 2008-07-22 |
| Multiple Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1941NCT01288898Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-testsRandomized · Double-masked · Basic science | Phase 1 | Completed | Drug: ASP1941, Placebo | Healthy | 48 | Mar 2008actual | — | 2011-02-03 |
| To Evaluate Whether Acetyl Salicylic Acid (Aspirin) and Darexaban (YM150) Interact in Their EffectsNCT01424332Composite assessment of pharmacodynamics of darexaban and darexaban glucuronideRandomized · Open-label | Phase 1 | Completed | Drug: Darexaban, Acetyl Salicylic Acid (ASA) | Pharmacodynamic and Pharmacokinetic Interaction, Healthy Subjects | 24 | Mar 2008actual | — | 2011-08-29 |
| Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney TransplantationNCT00296348Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.Randomized · Open-label · Prevention | Phase 3 | Completed | Drug: tacrolimus, mycophenolate mofetil, daclizumab, steroids | Kidney Transplantation | 198 | Feb 2008actual | — | 2015-06-26 |
| Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)NCT00431041results2010-01-11The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse EventRandomized · Triple-masked · Treatment | Phase 4 | Completed | Drug: solifenacin, oxybutynin immediate release | Overactive Bladder | 132 | Feb 2008actual | — | 2010-06-08 |
| Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal KeratoconjunctivitisNCT00567918SafetyOpen-label · Treatment | Phase 3 | Completed | Drug: FK506 | Keratoconjunctivitis, Conjunctivitis | 52 | Jan 2008actual | — | 2008-04-04 |
| A Study of Ramosetron Plus DX, Dexamethasone, Compared to Granisetron Plus DX for the Prevention of Vomiting and NauseaNCT00272285Proportion of patients without vomiting after the start of chemotherapy for 24 hoursRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Ramosetron, Granisetron | Vomiting, Nausea | 287 | Dec 2007actual | — | 2017-03-09 |
| A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant PatientsNCT00650468Assessment of death, graft loss, or severe acute rejectionRandomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: tacrolimus, CellCept, steroids (methylprednisone or prednisone) | Renal Transplantation | 397 | Dec 2007actual | — | 2011-11-17 |
| An Open Study Assessing Bioavailability of a Modified Formulation of Tacrolimus in Kidney Transplant RecipientsNCT00865137Assess pharmacokinetic parametersOpen-label · Treatment | Phase 3 | Completed | Drug: Tacrolimus, modified release | Kidney Transplantation | 27 | Dec 2007actual | — | 2014-07-18 |
| A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With InsomniaNCT00283946Mean wake time after sleep onset during the double-blind periodRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Zolpidem MR, Zolpidem | Sleep Initiation and Maintenance Disorders, Sleep Disorders | 876 | Nov 2007actual | — | 2014-08-20 |
| A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver RecipientsNCT00384202Creatinine clearanceNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Tacrolimus | Transplantation | 112 | Nov 2007actual | — | 2014-07-09 |
| Tacrolimus and Daclizumab Versus Tacrolimus and Steroids in Liver Recipients Receiving Sub-optimal GraftsNCT00321074Incidence of and time to first biopsy-proven and treatment requiring acute rejectionRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: TACROLIMUS | LIVER TRANSPLANTATION | 101 | Oct 2007actual | — | 2014-08-26 |
| An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in NeonatesNCT00818584Assessment of micafungin plasma pharmacokinetic parametersNon-randomized · Open-label | Phase 1 | Completed | Drug: Micafungin | Candida | 13 | Oct 2007actual | — | 2013-03-06 |
| A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPHNCT00510406Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPHRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: tamsulosin hydrochloride, solifenacin succinate, Placebo | Lower Urinary Tract Symptoms, Prostatic Hyperplasia | 919 | Sep 2007actual | — | 2014-08-20 |
| A Study to Assess the Long-Term Safety of Tacrolimus Cream in the Treatment of PsoriasisNCT00293917SafetyNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Tacrolimus Cream | Psoriasis | 658 | Aug 2007actual | — | 2008-02-13 |
| Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)NCT00353678Rate of total venous thromboembolism (VTE) during hospitalization phaseRandomized · Double-masked · Prevention | Phase 2 | Completed | Drug: YM150 | Thromboembolism | 1,141 | Aug 2007actual | — | 2013-03-21 |
| A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney RecipientsNCT00384137Creatinine clearanceNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Tacrolimus | Transplantation | 128 | Jul 2007actual | — | 2014-07-09 |
| A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With InsomniaNCT00999219Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: FK199B, Zolpidem | Sleep Initiation and Maintenance Disorders | 55 | Jul 2007actual | — | 2014-08-20 |
| Pilot Trial in Sleep Laboratory Setting to Compare the Physiology of Night Time Bladder Function in Subjects With Overactive Bladder (OAB) Versus Subjects That Have Insomnia and Healthy Normal SubjectsNCT01029015observationalNumber and proportion of voids associated with urgency | — | Completed | Procedure: cystometry, polysomnography | Bladder Function | 26 | Jul 2007actual | — | 2011-03-07 |
| A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy SubjectsNCT01121198Safety assessed by adverse events, vital signs, 12-lead ECG and lab-testsRandomized · Single-masked | Phase 1 | Completed | Drug: ASP1941, placebo | Healthy Volunteer, Pharmacokinetics of ASP1941 | 84 | Jul 2007actual | — | 2010-05-12 |
| Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.NCT00295594Incidence of and time to first biopsy proven acute rejection which requires treatment within 3 months following transplantationRandomized · Open-label · Prevention | Phase 3 | Completed | Drug: tacrolimus | Liver Transplantation | 627 | Jun 2007actual | — | 2014-08-26 |
| A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)NCT00337558Change from baseline in mean number of micturitions per 24 hours after 8 weeksRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: Solifenacin succinate · Behavioral: Simplified bladder training | Overactive Bladder, Urinary Incontinence, Urge Incontinence | 643 | May 2007actual | — | 2014-09-18 |
| First in Men Study of Single Oral Doses of ASP1941 in Healthy SubjectsNCT01288885Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-testsRandomized · Double-masked · Basic science | Phase 1 | Completed | Drug: ASP1941, Placebo | Healthy | 76 | May 2007actual | — | 2011-02-03 |
| Effect of Rapid Steroid Withdrawal on Subclinical Markers of RejectionNCT00133172Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR)Randomized · Quadruple-masked · Treatment | Phase 4 | Terminatedsponsor's stated reason: Varience of supply chain from that required by protocol | Drug: Tacrolimus, mycophenolate mofetil, Prednisone | Kidney Transplantation | 85 | Mar 2007actual | — | 2014-09-08 |
| LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With ChemotherapyNCT00328588Tumor response rate (CR+PR)Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: YM155 | Lung Cancer, Cancer of Lung, Cancer of the Lung, Non-Small Cell Lung Carcinoma, Carcinoma, Non-Small Cell Lung | 37 | Mar 2007actual | — | 2008-01-02 |
| A Study of YM178 in Patients With Symptomatic Overactive Bladder (DRAGON)NCT00337090Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: YM178 | Overactive Bladder | 1,108 | Mar 2007actual | — | 2013-07-02 |
| Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart SurgeryNCT00125320Effectiveness of RSD1235Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: RSD1235 | Atrial Fibrillation, Atrial Flutter | 190 | Feb 2007actual | — | 2007-12-24 |
| A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly SubjectsNCT01514825Cmax of YM150 assessed by its plasma concentration changeRandomized · Quadruple-masked | Phase 1 | Completed | Drug: YM150, Placebo | Healthy Elderly Subject, Pharmacokinetic of YM150 | 36 | Feb 2007actual | — | 2012-01-24 |
| Study of RSD1235 to Evaluate Safety in Patients With Atrial FibrillationNCT00281554Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minuteNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: RSD1235 | Atrial Fibrillation | 254 | Jan 2007actual | — | 2008-04-03 |
| A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.NCT00333112Change in micturitions per 24 hours from baseline to end of treatmentRandomized · Double-masked · Treatment | Phase 4 | Completed | Drug: solifenacin succinate, tamsulosin, placebo | Urinary Incontinence | 398 | Jan 2007actual | — | 2014-09-18 |
| A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.NCT00189826Incidence of and time to biopsy-proven acute rejectionsRandomized · Quadruple-masked · Prevention | Phase 3 | Completed | Drug: tacrolimus | Liver Transplantation | 475 | Dec 2006actual | — | 2014-07-09 |
| A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney TransplantationNCT00189839Time to and incidence of biopsy-proven acute rejectionsRandomized · Double-masked · Prevention | Phase 3 | Completed | Drug: tacrolimus | Kidney Transplantation | 699 | Dec 2006actual | — | 2014-07-09 |
| Study of Immunosuppressive Therapy Toxicities in Kidney Transplant Recipients at Regional or Satellite Community ClinicsNCT00902980observationalChange in renal function over 6-18 months estimated by change in serum creatinine and glomerular filtration rate (GFR) | — | Completed | Other: Chart Review | Kidney Transplantation | 264 | Dec 2006actual | — | 2014-09-18 |
| A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.NCT00379067The change from baseline to week 12 in mean number of nocturnal voidsRandomized · Double-masked · Treatment | Phase 4 | Completed | Drug: Tamsulosin OCAS, Placebo | Benign Prostatic Hyperplasia | 882 | Nov 2006actual | — | 2014-10-10 |
| A Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Adult VolunteersNCT01476800Pharmacokinetic (PK) variable for YM178: Area under the plasma concentration - time curve from time of dosing to infinity (AUCinf)Non-randomized · Open-label | Phase 1 | Completed | Drug: YM178 OCAS, Ketoconazole | Healthy Subjects, Pharmacokinetics of YM178 | 24 | Nov 2006actual | — | 2015-09-01 |
| Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly SubjectsNCT02796118Pharmacokinetics of ASP2151 in plasma: CmaxRandomized · Double-masked · Basic science | Phase 1 | Completed | Drug: ASP2151, Placebo | Healthy Subjects | 36 | Oct 2006actual | — | 2016-08-29 |
| Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.NCT00296309Renal function measured by creatinine clearanceRandomized · Open-label · Prevention | Phase 3 | Completed | Drug: Tacrolimus | Kidney Transplantation | 267 | Aug 2006actual | — | 2014-09-01 |
| A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic DermatitisNCT00106496percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatmentRandomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: Protopic, Corticosteroid, placebo | Dermatitis, Atopic | 410 | Jul 2006actual | — | 2014-09-18 |
| Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and CandidemiaNCT00189709Response rateRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Micafungin, fluconazole | Invasive Candidiasis, Candidemia | 24 | Jul 2006actual | — | 2008-01-02 |
| To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.NCT00296361Renal function as assessed by calculated creatinine clearance at month 6.Randomized · Open-label · Prevention | Phase 3 | Completed | Drug: Tacrolimus | Kidney Transplantation | 634 | Jul 2006actual | — | 2014-09-01 |
| Study of Micafungin in Patients With Invasive Candidiasis or CandidemiaNCT00105144Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) TherapyRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Micafungin, Caspofungin | Candidiasis, Candidemia | 611 | Apr 2006actual | — | 2014-09-18 |
| A Study to Investigate the Effect of YM150 on the Plasma Concentration of Digoxin in Healthy SubjectsNCT01514812Cmax of digoxin assessed by its plasma concentration changeRandomized · Quadruple-masked | Phase 1 | Completed | Drug: YM150, placebo, digoxin | Healthy, Pharmacokinetic of Digoxin | 24 | Apr 2006actual | — | 2012-01-24 |
| A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet FormulationNCT01478529Assessment of pharmacokinetics of mirabegron assessed by plasma concentrationRandomized · Open-label | Phase 1 | Completed | Drug: mirabegron OCAS, mirabegron | Pharmacokinetics of Mirabegron, Bioavailability, Healthy Subjects | 12 | Mar 2006actual | — | 2013-06-27 |
| YM443 in Subjects With Functional DyspepsiaNCT00102310Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: YM443 | Indigestion, Nausea | 416 | 2006-03-11actual | — | 2018-01-10 |
| Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)NCT00637143Graft SurvivalRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: Tacrolimus, Cyclosporine | Renal Transplantation, Chronic Renal Allograft Failure | 107 | Feb 2006actual | — | 2017-02-16 |
| Micafungin Versus AmBisome in Invasive Candidiasis and CandidemiaNCT00106288Investigator's assessment of overall treatment success. Success is defined as clinical (complete or partial) and mycological (eradication or presumed eradication) response at the End of Therapy.Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Micafungin, Liposomal Amphotericin B | Candidiasis | 637 | Dec 2005actual | — | 2014-09-18 |
| A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)NCT00189813Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: YM060 | Irritable Bowel Syndrome | 691 | Dec 2005actual | — | 2014-08-28 |
| Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus OintmentNCT00480610Number of exacerbations of atopic dermatitis requiring intervention.Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: tacrolimus ointment, Placebo ointment | Dermatitis, Atopic | 226 | Nov 2005actual | — | 2014-09-18 |
| Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus OintmentNCT00480896Number of exacerbations of atopic dermatitis requiring intervention.Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: tacrolimus ointment, Placebo ointment | Dermatitis, Atopic | 250 | Nov 2005actual | — | 2014-09-18 |
| A Study to Evaluate FK778 in Kidney Transplant PatientsNCT00189735Incidence of biopsy-proven acute rejection over the first 24 weeks.Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: FK778 | Kidney Transplantation, Renal Transplantation, Transplantation, Renal, Transplantation, Kidney, Grafting, Kidney | 364 | Oct 2005actual | — | 2008-04-17 |
| Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency SymptomsNCT00801944Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient Perception of Intensity of Urgency Scale at void (PPIUS) grades 3 and 4Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Solifenacin succinate, Placebo | Urinary Bladder, Overactive | 973 | Oct 2005actual | — | 2014-09-18 |
| To Evaluate the Blood and Urine Concentration and the Safety and Tolerability of Increasing Repeated Doses of Mirabegron (YM178) OCAS in Healthy Young and Elderly Males and Healthy Young and Elderly FemalesNCT01478503Pharmacokinetics of mirabegron assessed by plasma concentrationRandomized · Triple-masked | Phase 1 | Completed | Drug: mirabegron OCAS, Placebo | Pharmacokinetics, Healthy Subjects | 96 | Oct 2005actual | — | 2013-07-02 |
| A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant PatientsNCT00451932Event rate of biopsy-proven acute rejectionsRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: FK778 | Liver Transplantation | 303 | Sep 2005actual | — | 2008-04-17 |
| A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB)NCT00454896Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndromeRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: VESIcare®, placebo | Urinary Bladder, Overactive | 739 | Sep 2005actual | — | 2014-09-18 |
| Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult PatientsNCT00523952Rate of patients with at least 50% (i.e. at least moderate) improvement according to the Physician's global evaluation of clinical response between Baseline and the Week 12/End of Study VisitOpen-label · Treatment | Phase 3 | Completed | Drug: tacrolimus ointment | Dermatitis, Atopic | 303 | Sep 2005actual | — | 2014-09-01 |
| Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent AsthmaNCT00189787Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: tacrolimus | Asthma, Bronchial, Bronchial Asthma | 370 | Aug 2005actual | — | 2008-04-17 |
| Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive BladderNCT00454740Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome.Non-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: solifenacin succinate | Urinary Bladder, Overactive | 441 | Aug 2005actual | — | 2014-09-18 |
| Protopic Ointment in Children Atopic EczemaNCT00689832Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their modified Eczema Area and Severity Index (mEASI) in comparison to day 1Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: Tacrolimus 0.03%, Fluticasone 0.005% | Dermatitis, Atopic | 487 | Aug 2005actual | — | 2014-09-01 |
| Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent AsthmaNCT00189722Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Tacrolimus | Asthma, Bronchial, Bronchial Asthma | 160 | Jul 2005actual | — | 2008-04-17 |
| Protopic Ointment in Adult Atopic Eczema of the FaceNCT00690105Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their local mEASI score (mLEASI) compared to Baseline (day 1).Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: tacrolimus 0.1%, fluticasone 0.005 % | Dermatitis, Atopic | 577 | Jul 2005actual | — | 2014-09-01 |
| Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial FlutterNCT00115791To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythmRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: RSD1235, placebo | Atrial Flutter, Atrial Fibrillation | 276 | Jun 2005actual | — | 2008-04-01 |
| A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or InappropriateNCT00673556Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: alefacept, placebo | Chronic Plaque Psoriasis | 195 | May 2005actual | — | 2014-08-26 |
| Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder SymptomsNCT00463541To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptomsNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: solifenacin succinate | Urinary Bladder, Overactive | 2,225 | Apr 2005actual | — | 2014-09-18 |
| Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant RecipientsNCT00064701results2013-09-26Percentage of Participants With Efficacy FailureRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Tacrolimus Modified Release (MR), Tacrolimus, cyclosporine microemulsion, mycophenolate mofetil | Kidney Transplantation | 668 | Mar 2005actual | — | 2013-12-05 |
| Community Based Trial for AMEVIVE®NCT00168753To evaluate the safety of treating subjects with up to 12 additional doses of alefacept 15 mg IM following a standard 12-week course of AMEVIVE.Non-randomized · Open-label · Treatment | Phase 4 | Completed | Drug: Alefacept | Moderate to Severe Chronic Plaque Psoriasis | 114 | Mar 2005actual | — | 2014-09-08 |
| A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic ArthritisNCT00659412Proportion of patients achieving a score in the assessment system of the American College of Rheumatology Core Set Measurements of ACR 20, ACR 50 and ACR 70Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: Alefacept, Methotrexate, Placebo | Psoriatic Arthritis | 185 | Mar 2005actual | — | 2014-09-18 |
| Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic DermatitisNCT00691145The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 6/end of study (if before month 6) visitNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: tacrolimus ointment | Dermatitis, Atopic | 350 | Feb 2005actual | — | 2014-09-01 |
| Study to Evaluate the Response to Treatment and Safety of 0.03% Tacrolimus (FK506) Ointment Administered in Pediatric Patients With Moderate to Severe Atopic DermatitisNCT00691262The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 6/end of study (if before month 6) visitNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: tacrolimus ointment | Dermatitis, Atopic | 166 | Feb 2005actual | — | 2014-09-01 |
| Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal CandidiasisNCT00665639Comparative incidence of success, defined as complete clearing of esophageal lesionsRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: micafungin, caspofungin | Candidiasis, Oral | 454 | Dec 2004actual | — | 2014-08-20 |
| Study of the Safety and Efficacy of Tacrolimus Ointment in Treating Chronic Allergic Contact DermatitisNCT00667056Success using the Physician's Global Assessment (PGA)Randomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: tacrolimus ointment, placebo ointment | Dermatitis | 98 | Dec 2004actual | — | 2014-09-18 |
| Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque PsoriasisNCT00692172Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoringNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Alefacept | Psoriasis | 175 | Nov 2004actual | — | 2014-09-18 |
| Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic DermatitisNCT00801957Percentage of patients with serum bactericidal antibody titer of ≥ 8Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: tacrolimus ointment 0.03%, hydrocortisone acetate ointment 1%, hydrocortisone butyrate ointment 0.1% · Biological: Meningitec, AC VAX | Atopic Dermatitis | 260 | Nov 2004actual | — | 2014-09-18 |
| Solifenacin Succinate Versus Tolterodine 4mg Once DailyNCT00802373Change from baseline in mean number of micturitions per 24 hoursRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Solifenacin succinate, Tolterodine | Urinary Bladder, Overactive | 1,355 | Oct 2004actual | — | 2014-09-18 |
| Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney TransplantationNCT00693381Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantationRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Tacrolimus, Mycophenolate Mofetil, methylprednisolone and prednisone | Kidney Transplantation | 152 | Aug 2004actual | — | 2014-09-18 |
| Benefit of Early Protocol Biopsy and Treatment of Subclinical RejectionNCT00885820The incidence of interstitial fibrosis/tubular atrophy as defined by Banff interstitial and tubular chronic changes of ci + ct of 2 or more at 6 monthsRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: Tacrolimus, MMF, Corticosteroids (Prednisone) | Kidney Transplantation | 240 | Jul 2004actual | — | 2014-09-18 |
| A Study to Assess the Efficacy and Safety of Two Dosing Regimens of Alefacept in Subjects Weighing Between 100kg and 150kg With Moderate to Severe Chronic Plaque PsoriasisNCT00674063Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of ≥75 compared to baselineRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: alefacept | Chronic Plaque Psoriasis | 78 | Apr 2004actual | — | 2014-08-26 |
| Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TXNCT00693524Incidence of first acute rejectionRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: tacrolimus, Anti-IL2R AB, Mycophenolate mofetil, prednisone | Liver Transplantation | 94 | Mar 2004actual | — | 2014-08-26 |
| Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal CandidiasisNCT00666185Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapyRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Micafungin, Fluconazole | Candidiasis, Oral | 523 | Feb 2004actual | — | 2014-09-18 |
| A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic DermatitisNCT00666302Change in Eczema Area and Severity Index (EASI)Randomized · Single-masked · Treatment | Phase 4 | Completed | Drug: tacrolimus ointment, pimecrolimus cream | Dermatitis, Atopic | 413 | Nov 2003actual | — | 2014-09-18 |
| Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic DermatitisNCT00667160Change in Eczema Area and Severity Index (EASI)Randomized · Single-masked · Treatment | Phase 4 | Completed | Drug: tacrolimus ointment, pimecrolimus cream | Dermatitis, Atopic | 426 | Nov 2003actual | — | 2014-09-18 |
| Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICUNCT00048750Assessment of the incidence of a proven or probable invasive fungal infection, catheter tip fungal infection, or deep incisional surgical site infection during the studyRandomized · Quadruple-masked · Prevention | Phase 3 | Terminatedsponsor's stated reason: Inadequate enrollment | Drug: Micafungin, Placebo | Invasive Fungal Infections | 104 | Jun 2003actual | — | 2012-03-27 |
| Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic DermatitisNCT00666159Change Eczema Area and Severity Index (EASI)Randomized · Single-masked · Treatment | Phase 4 | Completed | Drug: tacrolimus ointment, pimecrolimus cream | Dermatitis, Atopic | 226 | May 2003actual | — | 2014-09-18 |
| Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for AspergillosisNCT00047827Incidence of treatment response defined as complete or partial responseNon-randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Inadequate enrollment | Drug: Micafungin, Liposomal Amphotericin B | Aspergillosis | 2 | Feb 2003actual | — | 2014-08-20 |
| To Compare Blood and Urine Concentrations of Mirabegron (YM178) in Healthy Poor or Extensive Metabolizers for CYP2D6 and to Assess the Effect of Mirabegron on the Metabolism of MetoprololNCT01478490Pharmacokinetics of mirabegron assessed by plasma concentrationNon-randomized · Open-label | Phase 1 | Completed | Drug: mirabegron, metoprolol | Pharmacokinetics of Mirabegron, Healthy Subjects | 28 | Nov 2002actual | — | 2014-04-10 |
| Study of FK463 for the Treatment of Invasive AspergillosisNCT00036166Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: FK463 | Aspergillosis | 326 | 2002-01-31actual | — | 2018-01-10 |
| Study of FK463 in the Treatment of Candidemia or Invasive CandidiasisNCT00036179Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: FK463 | Candidiasis | 75 | 2002-01-27actual | — | 2018-01-10 |
| Distribution of Tacrolimus in Skin, Atopic DermatitisNCT00534508Distribution of tacrolimus in the skin after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis.Open-label · Treatment | Phase 2 | Completed | Drug: Tacrolimus Ointment 0.1% | Dermatitis, Atopic | 14 | Jul 2001actual | — | 2014-09-18 |
| Study of CP-461 in Patients With Advanced Renal Cell CancerNCT00036036Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: CP-461 | Renal Cell Carcinoma | 14 | — | — | 2011-10-17 |
| Study Using CP-461 to Treat Advanced Prostate CancerNCT00036075Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: CP-461 | Prostate Cancer | 25 | — | — | 2011-10-17 |
| Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid ArthritisNCT00036153Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Tacrolimus (Prograf®), Methotrexate | Rheumatoid Arthritis | 210 | — | — | 2012-03-27 |
| Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a SulfonylureaNCT00036192Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: FK614 | Diabetes Mellitus | 200 | — | — | 2011-12-09 |
| Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic LeukemiaNCT00036257Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CP-461 | Chronic Lymphocytic Leukemia | 15 | — | — | 2011-10-17 |
| CP-461 for the Treatment of Crohn's DiseaseNCT00042055Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: CP-461 | Crohn's Disease | 30 | — | — | 2011-10-17 |
| A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)NCT00044057Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: YM872 (zonampanel), t-PA (alteplase) | Acute Ischemic Stroke | — | — | — | 2006-04-03 |
| A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke PatientsNCT00044070Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: YM872 (zonampanel) | Cerebrovascular Accident | — | — | — | 2006-04-03 |
| Efficacy and Safety Study of OSI-211 (Liposomal Lurtotecan) to Treat Recurrent Small Cell Lung CancerNCT00046787Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: OSI-211 (Liposomal Lurtotecan) | SCLC, Carcinoma, Small Cell | 47 | — | — | 2011-10-20 |
| Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian CancerNCT00046800Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: OSI-211 (Liposomal Lurtotecan) | Ovarian Neoplasms | 80 | — | — | 2011-10-20 |
| Study of FK788 in Subjects With Chronic Hepatitis C Virus InfectionNCT00047814Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: FK788 | Hepatitis C | 48 | — | — | 2011-12-09 |
| YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone TherapyNCT00048659Randomized · Double-masked · Treatment | Phase 2 | Terminated | Drug: YM598 | Hormone-Refractory Prostate Cancer, Prostatic Neoplasms | — | — | — | 2012-06-07 |
| YM598 in Patients With Rising PSA After Initial Therapy for Localized Prostate CancerNCT00050297Randomized · Double-masked · Treatment | Phase 2 | Terminated | Drug: YM598 | Prostate Cancer | — | — | — | 2012-06-07 |
| CP-461 in the Treatment of Patients With Advanced MelanomaNCT00060710Non-randomized · Open-label · Treatment | Phase 2 | Terminated | Drug: CP-461 | Malignant Melanoma | 35 | — | — | 2011-10-17 |
| Phase II Study of Taxotere in Combination With Exisulind in Non-Small Cell Lung Cancer (NSCLC) PatientsNCT00072618Non-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: Exisulind | NSCLC | 52 | — | — | 2011-10-20 |
| A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)NCT00073489Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: OSI-461 | Chronic Lymphocytic Leukemia | 23 | — | — | 2011-10-17 |
| A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer PatientsNCT00085826Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Exisulind | Non-Small Cell Lung Cancer | 600 | — | — | 2011-10-20 |
| A Randomized Study to Evaluate FK962 in Subjects With Mild to Moderate Alzheimer's DiseaseNCT00087724Randomized · Double-masked · Treatment | Phase 2 | Terminated | Drug: FK962 | Alzheimer's Disease | 510 | — | — | 2012-06-07 |
| Study of FK778 in Renal Transplant Recipients With Untreated BK NephropathyNCT00104338Change from baseline in urine BK viral loadRandomized · Open-label · Treatment | Phase 2 | Terminated | Drug: FK778 | BK Polyomavirus, Kidney Diseases | 45 | — | — | 2012-06-07 |
| A Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent AsthmaNCT00116103The primary outcome is the change in FEV1 from baseline to end-treatment.Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Tacrolimus Inhalation Aerosol | Asthma | — | — | — | 2012-06-07 |
| Famotidine in Subjects With Non-erosive Gastroesophageal Reflux DiseaseNCT00141960Rate of days with no heart burn in the treatment periodRandomized · Double-masked · Treatment | Phase 2/3 | Completed | Drug: Famotidine | Gastroesophageal Reflux | 480 | — | — | 2011-11-21 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19