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Clinical trials
catalyst calendar across sponsors →Studies where 4568.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.
351 interventional · 35 observational · 4 expanded access · 159 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 Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) TreatmentNCT04635111observationalFrequency of Hepatic Failure After Discontinuation of TURALIO™ (pexidartinib) | — | Recruiting | Drug: TURALIO™ | Hepatotoxicity, Tenosynovial Giant Cell Tumor | 30 | 2036-06-01 | in 3,574 d | 2025-10-06 |
| Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial CancerNCT07022483Disease-Free Survival as Assessed by Blinded Independent Central Review or by Histopathologic Confirmation of Disease Recurrence per Local AssessmentRandomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Trastuzumab Deruxtecan, Chemotherapy | Endometrial Cancer | 710 | 2032-03-23 | in 2,043 d | 2026-07-28 |
| A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic Breast CancerNCT07701941Part 1: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)Randomized · Open-label · Treatment | Phase 1/2 | Not yet recruiting | Drug: Patritumab deruxtecan, Trastuzumab deruxtecan | Hormone Receptor Positive, HER2-low or HER2-ultralow, Unresectable or Metastatic Breast Cancer | 220 | 2031-01-01 | in 1,596 d | 2026-07-14 |
| A First-in-Human Trial of DS3790a in Participants With Hematological MalignanciesNCT07220616Number of Participants Reporting Dose-limiting Toxicities, Treatment-emergent Adverse Events, Serious Adverse Events, Adverse Events of Special Interest, and Deaths in Participants With Hematological MalignanciesRandomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: DS3790a, Combination drug, Combination drug | Hematological Malignancies, B-cell Non-Hodgkin Lymphoma | 420 | 2030-11-30 | in 1,564 d | 2026-07-09 |
| A Study of DS-3939a in Participants With Solid TumorsNCT07739966Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)Non-randomized · Open-label · Treatment | Phase 1/2 | Not yet recruiting | Drug: DS-3939a, Pembrolizumab, Carboplatin, Pemetrexed, DS-1103a | Solid Tumor, Locally Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer | 400 | 2030-07-31 | in 1,442 d | 2026-07-31 |
| T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXdNCT07683754Progression-free Survival (PFS) Rate at 24 MonthsOpen-label · Treatment | Phase 3 | Not yet recruiting | Drug: Trastuzumab deruxtecan, Trastuzumab, Pertuzumab, Endocrine Therapy, Palbociclib | Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive, HR Positive | 200 | 2030-07-04 | in 1,415 d | 2026-07-23 |
| Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AMLNCT06578247Overall Survival (Arm A vs Arm B)Randomized · Triple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Quizartinib, Placebo, Chemotherapy | Leukemia | 700 | 2030-06-26 | in 1,407 d | 2026-07-02 |
| A Study of DS-1103a Combination Therapy in Participants With Advanced Solid TumorsNCT05765851Number of Participants with Dose-limiting Toxicities (Dose Escalation)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: DS-1103a, T-DXd | Advanced Solid Tumor | 108 | 2030-05-15 | in 1,365 d | 2026-07-28 |
| Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung CancerNCT06899126Progression Free Survival by Blinded Independent Central ReviewRandomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Trastuzumab Deruxtecan, pembrolizumab, Pemetrexed, Platinum Chemotherapy | Non-small Cell Lung Cancer | 686 | 2030-04-24 | in 1,344 d | 2026-07-21 |
| A Study of DS5361b in Participants With Advanced Solid TumorsNCT07182591Part 1 and 2: Number of participants with Dose-Limiting Toxicities (DLTs)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: DS5361b, Pembrolizumab | Advanced Solid Tumor | 192 | 2030-03-18 | in 1,307 d | 2026-05-14 |
| Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic AlterationsNCT05215340Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With PembrolizumabRandomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: Datopotamab Deruxtecan, Pembrolizumab | Metastatic Non Small Cell Lung Cancer | 740 | 2030-03-04 | in 1,293 d | 2026-08-19 |
| Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial CarcinomaNCT07129993Overall Response Rate - Part A (Phase 2)Randomized · Open-label · Treatment | Phase 2/3 | Recruiting | Drug: Dato-DXd, Carboplatin, Cisplatin, Gemcitabine | Urothelial Cancer, Bladder Cancer | 630 | 2029-06-01 | in 1,017 d | 2026-07-27 |
| Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)NCT05555732Progression-free Survival Based on Blinded Independent Central Review in All Randomized ParticipantsRandomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: Datopotamab Deruxtecan, Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin | Metastatic Non Small Cell Lung Cancer | 1,170 | 2029-05-11 | in 996 d | 2026-06-23 |
| A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid TumorsNCT07015697Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: Trastuzumab Deruxtecan | Recurrent or Metastatic Solid Tumors | 76 | 2028-12-31 | in 865 d | 2026-07-09 |
| First-in-Human Trial of DS-2243a in Participants With Advanced Solid TumorsNCT06644755Part 1: Number of participants with Dose-Limiting Toxicities at each dose level of DS-2243aOpen-label · Treatment | Phase 1 | Recruiting | Drug: DS-2243a | Solid Tumors, Sarcoma | 150 | 2028-11-30 | in 834 d | 2025-07-24 |
| A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed DyslipidaemiaNCT07206472observationalIncidence of adverse events | — | Recruiting | Drug: Combination of bempedoic acid and ezetimibe | Primary Hypercholesterolaemia, Mixed Dyslipidemia | 2,120 | 2028-11-22 | in 826 d | 2026-07-31 |
| A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid TumorsNCT06244485Number of Participants Reporting Dose-limiting Toxicities (Part 1 Dose Escalation)Non-randomized · Open-label · Treatment | Phase 1 | Active, not recruiting | Drug: Valemetostat tosylate, T-DXd, Dato-DXd | Advanced Solid Tumor | 98 | 2028-11-01 | in 805 d | 2026-07-21 |
| Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)NCT06819007Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ populationRandomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Trastuzumab Deruxtecan, Bevacizumab | Ovarian Cancer | 582 | 2028-11-01 | in 805 d | 2026-07-02 |
| A Study of DS3610a in Participants With Advanced Solid TumorNCT07159126Dose Limiting ToxicitiesNon-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: DS3610a | Solid Tumors, Metastatic Solid Tumors | 70 | 2028-09-01 | in 744 d | 2025-12-10 |
| A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)NCT06330064Objective Response Rate (ORR) as Assessed by InvestigatorNon-randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: Ifinatamab deruxtecan | Recurrent or Metastatic Solid Tumors | 680 | 2028-07-25 | in 706 d | 2026-08-05 |
| Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete RemissionNCT06824168Serious Treatment Emergent Adverse Events (TEAEs)Randomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: Quizartinib High Dose, Quizartinib Low Dose | Acute Myeloid Leukemia, Leukemia | 130 | 2028-06-06 | in 657 d | 2026-06-22 |
| A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)NCT06644781Overall Survival (OS)Randomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Ifinatamab deruxtecan, Docetaxel, Paclitaxel, Irinotecan hydrochloride (HCl) | Esophageal Squamous Cell Carcinoma | 510 | 2028-06-01 | in 652 d | 2026-08-04 |
| Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction CancerNCT06731478Progression Free Survival (PFS)Randomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Trastuzumab Deruxtecan, pembrolizumab, Trastuzumab, Chemotherapy | Gastric Cancer, Gastroesophageal Junction Cancer | 726 | 2028-06-01 | in 652 d | 2026-08-10 |
| A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular EventsNCT07474649Annualised change in percentage plaque burden (Δ%PB)Open-label · Treatment | Phase 3 | Not yet recruiting | Drug: Bempedoic acid, Ezetimibe, Rosuvastatin, Atorvastatin | Coronary Atherosclerosis, Mixed Dyslipidemia, Hypercholesterolemia | 103 | 2028-06-01 | in 652 d | 2026-08-07 |
| A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic AlterationsNCT06644768Phase 1b: Number of Participants with Dose-Limiting ToxicitiesRandomized · Open-label · Treatment | Phase 1/2 | Active, not recruiting | Drug: valemetostat tosylate, pembrolizumab | Non-small Cell Lung Cancer, Lung Cancer | 137 | 2028-03-30 | in 589 d | 2026-07-28 |
| A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)NCT06210776observationalReal World Time to Next Treatment (rwTTNT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer | — | Recruiting | Drug: Trastuzumab deruxtecan | HER2-positive Breast Cancer, HER2-low Breast Cancer, Breast Cancer, Advanced Cancer | 800 | 2028-03-01 | in 560 d | 2026-01-12 |
| A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate CancerNCT07189403Number of Participants Reporting Dose-limiting Toxicities (DLTs), Treatment-emergent Adverse Events (TEAEs), TEAEs Associated With Treatment Discontinuation, Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) - All PatientsOpen-label · Treatment | Phase 1 | Recruiting | Drug: DS9051b | Advanced or Metastatic Adrenocortical Carcinoma, Metastatic Castration-resistant Prostate Cancer | 40 | 2028-03-01 | in 560 d | 2026-05-22 |
| A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube CancerNCT06161025Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part A)Randomized · Open-label · Treatment | Phase 2/3 | Recruiting | Drug: R-DXd, Paclitaxel, Topotecan, PLD | Solid Cancer | 860 | 2028-02-29 | in 559 d | 2026-07-28 |
| A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)NCT07244341Part 1: Number of participants with Dose-Limiting Toxicities (DLTs)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: Valemetostat, Darolutamide | Metastatic Castration-resistant Prostate Cancer | 60 | 2028-01-31 | in 530 d | 2026-05-15 |
| A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung CancerNCT06203210Overall Survival (OS)Randomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Ifinatamab deruxtecan, Topotecan, Amrubicin, Lurbinectedin | Small Cell Lung Cancer | 540 | 2028-01-30 | in 529 d | 2026-08-06 |
| First-in-Human Trial of DS1025a in Participants With Advanced Solid TumorsNCT07681882Number of Participants Reporting Dose-limiting Toxicities (DLTs)Open-label · Treatment | Phase 1 | Recruiting | Drug: DS1025a | Advanced Solid Tumor, Metastatic Solid Tumor, Unresectable Solid Tumor | 45 | 2028-01-21 | in 520 d | 2026-08-10 |
| Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast CancerNCT05950945Time From the Start of T-DXd to Initiation of Subsequent Anticancer Treatment (TTNT)Non-randomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Trastuzumab Deruxtecan | Breast Cancer | 250 | 2027-10-01 | in 408 d | 2026-06-12 |
| A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)NCT06660654Objective Response Rate as Assessed by the Investigator (All Cohorts Except ccRCC)Non-randomized · Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: Raludotatug deruxtecan | Advanced Solid Tumor, Metastatic Solid Tumors | 200 | 2027-09-30 | in 407 d | 2026-05-29 |
| A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid TumorsNCT06172478Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)Open-label · Treatment | Phase 2 | Recruiting | Drug: HER3-DXd | Advanced Solid Tumor, Melanoma, Head and Neck Cancer, Gastric Cancer, Ovarian Carcinoma, Cervical Cancer, Endometrial Cancer, Bladder Cancer, Esophageal Cancer, Pancreatic Carcinoma, Prostate Cancer, Non-small Cell Lung Cancer (NSCLC), Lung Cancer, Breast Cancer | 740 | 2027-09-01 | in 378 d | 2026-08-10 |
| Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in ChinaNCT06846996observationalReal-world Time to Treatment Failure (rwTTF) | — | Recruiting | Drug: Trastuzumab deruxtecan (T-DXd) | HER2-positive Gastric Cancer, HER2-positive Gastroesophageal Junction | 260 | 2027-07-31 | in 346 d | 2026-08-18 |
| A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid TumorsNCT04419532Number of participants with dose-limiting toxicitiesOpen-label · Treatment | Phase 1 | Active, not recruiting | Drug: DS-1055a | Solid Tumor, Advanced Cancer, Metastatic Solid Tumor | 40 | 2027-07-01 | in 316 d | 2026-03-20 |
| Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the BloodNCT03793478Number of dose-limiting toxicities (Phase 1)Open-label · Treatment | Phase 1/2 | Active, not recruiting | Drug: Quizartinib, Fludarabine, Cytarabine, Intrathecal (IT) triple chemotherapy prophylaxis, Etoposide | Acute Myeloid Leukemia | 65 | 2027-05-01 | in 255 d | 2026-04-01 |
| Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant TumorsNCT04145622Evaluate the incidence of dose-limiting toxicities (DLTs)Non-randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: Ifinatamab deruxtecan (I-DXd) | Advanced Solid Tumor, Malignant Solid Tumor | 250 | 2027-04-30 | in 254 d | 2026-05-29 |
| Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN)NCT06809764observationalProgression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS) | — | Recruiting | Other: No drug | Non-small Cell Lung Cancer | 150 | 2027-02-12 | in 177 d | 2026-08-18 |
| Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular DystrophyNCT04433234Incidence of Adverse Events (AEs)Non-randomized · Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: DS-5141b | Duchenne Muscular Dystrophy | 8 | 2027-01-31 | in 165 d | 2025-09-19 |
| First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)NCT03401385Number of participants with dose-limiting toxicitiesRandomized · Open-label · Treatment | Phase 1 | Active, not recruiting | Drug: Datopotamab Deruxtecan (Dato-DXd), Steroid Containing Mouthwash · Other: Non-Steroid Containing Mouthwash | Hormone Receptor Positive Breast Cancer, Triple Negative Breast Cancer, Non-small Cell Lung Cancer | 890 | 2027-01-01 | in 135 d | 2025-10-21 |
| Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic ImpairmentNCT06740799Pharmacokinetic Parameter: CmaxNon-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: Quizartinib | Hepatic Impairment | 12 | 2026-10-31 | in 73 d | 2026-04-01 |
| First-in-Human Study of DS-3939a in Participants With Advanced Solid TumorsNCT05875168Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939aRandomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: DS-3939a | Advanced Solid Tumor, Metastatic Solid Tumor | 590 | 2026-10-20 | in 62 d | 2026-08-12 |
| A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)NCT06362252Number of Participants Reporting Dose-limiting Toxicities Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A)Randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: Ifinatamab deruxtecan, Atezolizumab, Carboplatin | Extensive Stage-small Cell Lung Cancer | 123 | 2026-09-30 | in 42 d | 2026-02-06 |
| Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)NCT04704934Overall Survival in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With PaclitaxelRandomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: Trastuzumab deruxtecan, Ramucirumab, Paclitaxel | Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma | 490 | 2026-08-31 | in 12 d | 2026-05-27 |
| A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)NCT06174987Number of Participants Reporting Treatment-emergent Adverse Events Leading to Study Drug discontinuation and/or Dose Reduction, Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (AESIs)Open-label · Treatment | Phase 3 | Recruiting | Drug: T-DXd | Advanced Cancer, Metastatic Cancer | 50 | 2026-08-03 | — | 2025-10-15 |
| A Study to Evaluate the Safety and Effectiveness of Mirogabalin in Chinese Adult Patients With Diabetic Peripheral Neuropathic Pain (DPNP) in Real-world Clinical Practice Setting (ReMIssion Study)NCT06812117observationalProportion of participants with any treatment related adverse events (TRAEs) | — | Active, not recruiting | Other: No Drug | Diabetic Peripheral Neuropathic Pain | 721 | 2026-07-24 | — | 2026-03-30 |
| A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian TumorsNCT04707248Number of Participants With Dose-limiting toxicities (DLTs)Non-randomized · Open-label · Treatment | Phase 1 | Active, not recruiting | Drug: DS-6000a, DS-6000a | Renal Cell Carcinoma, Ovarian Tumor | 179 | 2026-04-30 | — | 2025-07-28 |
| U3-1402 in Metastatic or Unresectable Non-Small Cell Lung CancerNCT03260491Dose-limiting toxicities (DLTs) during dose escalationNon-randomized · Open-label · Treatment | Phase 1 | Active, not recruiting | Drug: HER3-DXd (FL-DP), HER3-DXd (CTM-1 Lyo-DP), HER3-DXd (CTM-3 Lyo-DP) | Non-Small Cell Lung Cancer (NSCLC) | 312 | 2026-03-31 | — | 2026-03-05 |
| Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast CancerNCT07092254observationalTreatment sequencing before the diagnosis of advanced, metastatic TNBC (i.e., all treatments received for early TNBC if initially diagnosed with earlier-stage disease) | — | Active, not recruiting | Drug: No drug | Triple Negative Breast Cancer | 760 | 2025-11-28actual | — | 2026-06-17 |
| DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung CancerNCT04042701Dose-limiting toxicities (DLTs), Part 1Non-randomized · Open-label · Treatment | Phase 1 | Active, not recruiting | Drug: Trastuzumab deruxtecan (DS-8201a), Trastuzumab deruxtecan (DS-8201a), Pembrolizumab | Breast Cancer, Non-small Cell Lung Carcinoma | 115 | 2025-07-21actual | — | 2025-11-18 |
| A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)NCT04622319Invasive Disease-free Survival (IDFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) TreatmentRandomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: DS-8201a, T-DM1 | HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer | 1,600 | 2025-07-02actual | — | 2026-05-15 |
| Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)NCT05280470Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLCRandomized · Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: Ifinatamab Deruxtecan (I-DXd) | Extensive-stage Small-cell Lung Cancer | 187 | 2025-03-03actual | — | 2026-02-25 |
| HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung CancerNCT04676477Dose Escalation: Incidence of Dose-limiting Toxicities (DLT), Treatment-emergent Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI)Randomized · Open-label · Treatment | Phase 1 | Active, not recruiting | Drug: HER3-DXd, HER3-DXd, Osimertinib, Osimertinib, HER3-DXd, HER3-DXd, Osimertinib | Non-Small Cell Lung Cancer (NSCLC) | 246 | 2025-01-31actual | — | 2025-06-22 |
| HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI TherapyNCT05338970Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Based on RECIST v1.1Randomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: Patritumab Deruxtecan, Platinum-based chemotherapy | Nonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR Exon 19 Deletion | 586 | 2024-05-31actual | — | 2025-01-31 |
| Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)NCT04656652results2025-07-23Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus DocetaxelRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Active, not recruiting | Drug: DS-1062a, Docetaxel | Non-small Cell Lung Cancer | 605 | 2024-05-10actual | — | 2026-07-31 |
| Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02)NCT04526691Number of Participants with Dose-limiting Toxicities (DLTs) and Treatment-emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 1 | Active, not recruiting | Drug: Datopotamab deruxtecan, KEYTRUDA®, Carboplatin, Cisplatin | Advanced or Metastatic NSCLC | 145 | 2024-04-14actual | — | 2026-05-15 |
| Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)NCT04703192results2024-07-22Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Active, not recruiting | Drug: Valemetostat Tosylate | Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma | 155 | 2023-05-10actual | — | 2026-07-20 |
| A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II GliomaNCT04458272Overall response rate (ORR) assessed by Independent Efficacy Review CommitteeOpen-label · Treatment | Phase 2 | Active, not recruiting | Drug: DS-1001b | WHO Grade II Glioma | 25 | 2023-03-10actual | — | 2026-03-20 |
| DS-3201b in Participants With LymphomasNCT02732275Dose Escalation Period: Number of participants with dose-limiting toxicities (DLTs)Open-label · Treatment | Phase 1 | Active, not recruiting | Drug: DS-3201b, DS-3201b | Lymphoma, Malignant, Non-hodgkin Lymphoma | 100 | 2022-12-31actual | — | 2026-04-28 |
| HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung CancerNCT04619004results2024-04-02Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)Randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Active, not recruiting | Drug: Patritumab Deruxtecan (Fixed dose), Patritumab Deruxtecan (Up-Titration) | Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor | 277 | 2022-11-21actual | — | 2026-07-17 |
| Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]NCT03734029results2023-06-15Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast CancerRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Active, not recruiting | Drug: Trastuzumab deruxtecan (DS-8201a), Capecitabine, Eribulin, Gemcitabine, Paclitaxel, Nab-paclitaxel | Breast Cancer | 557 | 2022-01-11actual | — | 2025-10-06 |
| A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCTNCT04488822results2023-04-27Overall Response Rate (ORR) of Pexidartinib Based on RECIST 1.1 of Asian Participants With Symptomatic Tenosynovial Giant Cell Tumor (TGCT) at Week 25Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Active, not recruiting | Drug: Pexidartinib | Tenosynovial Giant Cell Tumor | 40 | 2021-10-27actual | — | 2026-06-26 |
| DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]NCT03529110results2022-04-29Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and TaxaneRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Active, not recruiting | Drug: Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1) | Breast Cancer | 524 | 2021-05-21actual | — | 2025-10-21 |
| Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and AtorvastatinNCT07268625Pharmacokinetic Parameter Area Under the Curve (AUC)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Bempedoic acid, Ezetimibe, Atorvastatin | Healthy Subjects | 58 | 2026-02-24actual | — | 2026-02-27 |
| A Study of DS-9606a in Patients With Advanced Solid TumorsNCT05394675Number of Participants with Dose-Limiting Toxicities (DLT) in Participants Receiving DS-9606aNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: It was Daiichi Sankyo, Inc.'s decision to discontinue further internal development of DS-9606a | Drug: DS-9606a | Advanced Cancer, Metastatic Cancer, Germ Cell Tumor | 88 | 2026-02-06actual | — | 2026-03-20 |
| A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and AtorvastatinNCT07235189Pharmacokinetic Parameter Area Under the Curve (AUC)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Bempedoic acid, Ezetimibe, Atorvastatin | Healthy Subjects | 58 | 2026-01-28actual | — | 2026-02-02 |
| Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and RosuvastatinNCT07201545Pharmacokinetic Parameter Area Under the Curve (AUC)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Bempedoic acid, Ezetimibe, Rosuvastatin | Healthy Subjects | 58 | 2025-12-10actual | — | 2025-12-18 |
| Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and RosuvastatinNCT07182383Pharmacokinetic Parameter Area Under the Curve (AUC)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Bempedoic acid, Ezetimibe, Rosuvastatin | Healthy Subjects | 58 | 2025-11-24actual | — | 2025-12-16 |
| A Study to Investigate the Effectiveness and Safety of Bempedoic Acid in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia in TaiwanNCT06925100Percentage change from baseline in LDL-C level at Week 12Open-label · Treatment | Phase 4 | Completed | Drug: Bempedoic acid 180 mg tablet | Primary Hypercholesterolemia or Mixed Hyperlipidemia | 180 | 2025-10-15actual | — | 2025-12-08 |
| A Study to Investigate the Prevalence of Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ and Characterize the Clinicopathologic Features of Gynecologic Cancers in TaiwanNCT06925113observationalTo understand the prevalence rate of HER2 IHC 3+ in recurrent advanced endometrial cancer, ovarian cancer, and cervical cancer in Taiwan | — | Completed | — | Cervical Cancers, Endometrial Cancer, Ovarian Cancer | 509 | 2025-08-31actual | — | 2025-11-17 |
| A Study of Treatment Patterns in HER2-positive Unresectable and Advanced Gastric/ Gastroesophageal Junction Cancer in ChinaNCT06585501observationalPercentage of patients receiving first-line, second-line, and third-line anti-tumor regimens | — | Completed | Other: No drug | Gastric Cancer, Gastroesophageal Junction Cancer | 805 | 2025-07-30actual | — | 2025-08-21 |
| A Study of DS-1471a In Subjects With Advanced Solid TumorsNCT06074705Number of Participants With Dose-limiting Toxicities Following Treatment With DS-1471a (Dose Escalation)Non-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: The study was terminated by the sponsor due to a business decision. | Drug: DS-1471a | Advanced Solid Tumor | 17 | 2025-07-29actual | — | 2025-08-22 |
| A Study to Evaluate Effectiveness and Safety of Edoxaban in Patients 80 Years of Age or Older With Nonvalvular Atrial FibrillationNCT05804747observationalNumber of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality | — | Completed | Drug: Edoxaban | Atrial Fibrillation | 1,204 | 2025-07-28actual | — | 2025-09-26 |
| Real-World Pharmacological Treatment Pattern of Neuropathic Pain in ChinaNCT06546202observationalProportion of participants receiving different treatment regimens (targeted medications or combinations) and related medication categories in participants with DPNP or CIPN | — | Completed | Other: No Drug | Diabetic Peripheral Neuropathic Pain, Chemotherapy-induced Peripheral Neuropathy, Neuropathic Pain | 1,271 | 2025-07-18actual | — | 2025-07-23 |
| Real-world Outcomes of Patients With HER2+ Metastatic Breast Cancer After Treatment With Trastuzumab DeruxtecanNCT06833268observationalReal-world Progression-free Survival (rwPFS) | — | Completed | Other: No drug | HER2-positive Breast Cancer | 228 | 2025-06-16actual | — | 2025-07-08 |
| A Study to Evaluate QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart RateNCT06772246Change in Heart RateOpen-label · Treatment | Phase 1 | Completed | Drug: Quizartinib · Other: Placebo | Healthy Subjects | 70 | 2025-06-12actual | — | 2025-08-01 |
| Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6iNCT06975371observationalReal-world progression-free survival (rwPFS) | — | Completed | Other: No drug | Advanced/Metastatic HER2-negative Breast Cancer | 1,415 | 2025-05-08actual | — | 2025-10-07 |
| A Study of DS-7011a in Patients With Systemic Lupus ErythematosusNCT05638802results2026-05-28Number of Participants With Treatment-emergent Adverse Events Following Administration With DS-7011a in Participants With Systemic Lupus ErythematosusRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: DS-7011a, Placebo | Systemic Lupus Erythematosus | 26 | 2025-04-01actual | — | 2026-05-28 |
| A Study of Real-world Treatment Patterns and Outcomes in Chinese Advanced NSCLC Patients Who Previously Received at Least 2 Line TreatmentsNCT06617390observationalPercentage of real-world treatment regimens for second- or third-line therapy in patients with advanced NSCLC | — | Completed | Other: No drug | Non-small Cell Lung Cancer (NSCLC) | 1,041 | 2025-01-26actual | — | 2025-08-03 |
| A Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherton SyndromeNCT05979831results2026-05-14Number of Participants With Treatment-emergent Adverse EventsRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: The study was terminated based on a business decision by the Sponsor. | Drug: DS-2325a · Other: Placebo | Netherton Syndrome | 9 | 2025-01-06actual | — | 2026-05-14 |
| A Study Assessing Risk Factors for Oral Mucositis/Stomatitis and Ocular Surface Events in NSCLC and Breast CancerNCT06686602observationalPatient Demographics in NSCLC and Breast Cancer Patients With Oral Mucositis/Stomatitis or OSE Compared with Patients Without Oral Mucositis/Stomatitis or OSE | — | Completed | Other: No drug | Advanced/Metastatic NSCLC, Advanced/Metastatic HER2-negative Breast Cancer | 13,759 | 2024-12-16actual | — | 2025-03-19 |
| Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy SubjectsNCT06740825Pharmacokinetic Parameter: CmaxRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Quizartinib, Rufinamide | Healthy Subjects | 32 | 2024-12-09actual | — | 2024-12-18 |
| Real-world Study on Edoxaban Treatment for Patients With Non-valvular Atrial Fibrillation in ChinaNCT04747496observationalIncidence (including 95% confidence intervals) of major bleeding events following edoxaban treatment | — | Completed | Drug: Edoxaban | Non-valvular Atrial Fibrillation | 5,000 | 2024-11-27actual | — | 2025-01-09 |
| A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT05400369Number of Participants Achieving Clinical Efficacy in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: Sitafloxacin, Moxifloxacin Hydrochloride | COPD Exacerbation Acute | 140 | 2024-09-25actual | — | 2025-01-09 |
| An Observational Study Investigating the Change in Blood Cholesterol With Mevalotin® Tablet Administration in Korean Menopausal Women Aged 50 Years or More Who Require Treatment of DyslipidemiaNCT05120895observationalChange from baseline in low-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration | — | Completed | Drug: Mevalotin | Dyslipidemia | 3,060 | 2024-09-02actual | — | 2025-07-23 |
| Study on Prevalence and Impact of Brain Metastases on Survival in Lung Cancer by Line of TreatmentNCT06557967observationalOverall Survival (OS) of (AGA+/-) mNSCLC Participant With And Without Brain Metastases by Line of Therapy | — | Completed | Other: No drug | Non-small Cell Lung Cancer, Lung Cancer, Metastatic Cancer, Brain and Central Nervous System Cancer | 22,517 | 2024-06-28actual | — | 2024-12-09 |
| EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab DeruxtecanNCT05458401observationalReal-World Time-to-Treatment Discontinuation In Participants Treated With Trastuzumab Deruxtecan (T-DXd) | — | Completed | Drug: Trastuzumab deruxtecan | HER2-positive Breast Cancer | 256 | 2023-12-01actual | — | 2024-03-15 |
| Real-World Observational Study to Describe Treatment Patterns in Patients With HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer in East AsiaNCT05606094observationalPercentage of Participants Receiving Each Regimen in Each Line of Treatment (LOT) | — | Completed | — | Gastric Cancer | 450 | 2023-11-30actual | — | 2023-12-15 |
| Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast CancerNCT06040593observationalEvent-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer | — | Completed | Other: No drug | Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer | 927 | 2023-11-30actual | — | 2024-02-26 |
| A Study of DS-1211b in Individuals With PseudoXanthoma ElasticumNCT05569252results2024-12-31Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211bRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: DS-1211b · Other: Placebo | Pseudoxanthoma Elasticum | 65 | 2023-11-21actual | — | 2024-12-31 |
| A Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients of China With HER2-positive Unresectable or Metastatic Breast CancerNCT05769751observationalPercentage of Participants Receiving Each Regimen in Each Treatment Line | — | Completed | Other: Electronic medical record and hospital information system or other available resources | HER2-positive Breast Cancer | 865 | 2023-07-25actual | — | 2023-08-16 |
| Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With PexidartinibNCT04526704results2024-12-30Number of Treatment-Free Participants at 12 Months In The Treatment-free/Re-treatment CohortNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Pexidartinib | Tenosynovial Giant Cell Tumor | 32 | 2023-07-07actual | — | 2024-12-30 |
| Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary InterventionNCT04519944observationalUsage of Peri- and Post-procedural Anticoagulation and Antiplatelet Therapy in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention | — | Completed | Drug: Edoxaban | Non-valvular Atrial Fibrillation | 666 | 2023-07-06actual | — | 2023-08-02 |
| A Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy SubjectsNCT05583669Number of Participants with Any Treatment-emergent Adverse Events Following Administration of DS-2325aRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: DS-2325a, Placebo | Netherton Syndrome | 24 | 2023-05-11actual | — | 2023-05-18 |
| A Dose Finding Study of VN-0200NCT05547087Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing ActivityRandomized · Quadruple-masked · Prevention | Phase 2 | Completed | Biological: VN-0200 | Respiratory Syncytial Virus Infections | 342 | 2023-04-11actual | — | 2024-02-29 |
| A Study of Prevalence of HER3 Expression in Non-Small Cell Lung CancerNCT05769764observationalHER3 Expression Prevalence Estimate for the NSCLC Population, Overall | — | Completed | Other: Archival tissue specimen and immunohistochemistry staining | Non-small Cell Lung Cancer | 225 | 2023-04-06actual | — | 2023-04-10 |
| A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in JapanNCT04703322results2025-03-03Dose-limiting Toxicity (DLT) in Part 1Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Pexidartinib | Tenosynovial Giant Cell Tumor | 9 | 2023-03-20actual | — | 2026-06-24 |
| Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)NCT04484142results2024-04-03Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR)Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: DS-1062a | Non-small Cell Lung Cancer | 137 | 2023-03-10actual | — | 2026-03-24 |
| A Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenous Doses of DS-2325a in Healthy SubjectsNCT05388903Number of Participants with Any Treatment-emergent Adverse Events Following Administration of DS-2325aRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DS-2325a, DS-2325a, Placebo, Placebo | Netherton Syndrome | 64 | 2023-01-26actual | — | 2023-03-06 |
| A Study of a Single Ascending Dose Study of DS-7011a in Healthy SubjectsNCT05203692Number of Participants with Treatment-emergent Adverse Events Following Administration with DS-7011a in Healthy ParticipantsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DS-7011a, Placebo | Systemic Lupus Erythematosus | 80 | 2023-01-25actual | — | 2023-04-11 |
| Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)NCT04644237results2024-01-30Percentage of Participants With Confirmed Objective Response Rate by Blinded Independent Central Review Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung CancerRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Trastuzumab deruxtecan | Non-Small Cell Lung Cancer | 152 | 2022-12-23actual | — | 2025-11-21 |
| Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal CancerNCT04744831results2024-01-02Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review Following IV Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2-overexpressing Metastatic Colorectal CancerRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: DS-8201a 5.4 mg/kg Q3W, DS-8201a 6.4 mg/kg Q3W | Advanced Colorectal Cancer | 122 | 2022-11-01actual | — | 2026-01-14 |
| Pseudoxanthoma Elasticum (PXE) Natural History Biomarkers in PXE Individuals and Their Biological Non-PXE SiblingsNCT05025722observationalMean Plasma Levels of Inorganic Pyrophosphate (PPi) | — | Completed | Other: Non Interventional | Pseudoxanthoma Elasticum | 48 | 2022-08-11actual | — | 2022-09-06 |
| DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]NCT03523585results2023-06-26Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab EmtansineRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Trastuzumab deruxtecan, Capecitabine, Lapatinib, Trastuzumab | Breast Cancer | 608 | 2022-06-30actual | — | 2026-02-27 |
| Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)NCT02798471results2023-03-06Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)Randomized · Single-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Edoxaban, Standard of Care | Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT) | 290 | 2022-05-24actual | — | 2025-02-28 |
| Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial FibrillationNCT02944019observationalPercentage of Participants Experiencing Real-World Safety Data Events within 4 Years | — | Completed | Drug: Edoxaban | Atrial Fibrillation | 13,980 | 2022-04-13actual | — | 2022-06-01 |
| DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST)NCT04276415results2024-02-15Number of Participants With Dose-limiting Toxicities (DLT) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Terminatedsponsor's stated reason: The study was terminated due to a business decision. | Drug: DS-6157a | Gastrointestinal Stromal Tumors | 34 | 2022-03-11actual | — | 2024-02-15 |
| Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)NCT03723681Number of Participants with Dose-Limiting ToxicitiesNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Quizartinib | Acute Myeloid Leukemia (AML) | 7 | 2022-03-03actual | — | 2022-07-29 |
| A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal CancerNCT04479436results2025-05-18Objective Response Rate (ORR) As Assessed By Blinded Independent Central Review (BICR) Following Administration of U3-1402 In Participants With Advanced or Metastatic Colorectal CancerNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Study was terminated early given the Interim Analysis for Part 1 (signal finding) did not meet pre-specified criteria and will not proceed to Part 2. Sponsor will proceed closing the study. | Drug: Patritumab Deruxtecan | Metastatic Colorectal Cancer | 40 | 2022-02-03actual | — | 2025-05-18 |
| A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic PainNCT04094662Average Daily Pain Score (ADPS)Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Mirogabalin, Placebo | Diabetic Peripheral Neuropathic Pain | 393 | 2022-01-17actual | — | 2022-10-24 |
| Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant TumorsNCT02675491number and severity of adverse eventsOpen-label · Treatment | Phase 1 | Completed | Drug: DS-6051b | Advanced Solid Malignant Tumors | 15 | 2021-12-27actual | — | 2024-12-16 |
| Study of Single-Ascending Doses of DS-6016a in Healthy Japanese SubjectsNCT04818398Number of Participants Reporting Treatment-emergent Adverse EventsRandomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: DS-6016a, Placebo | Fibrodysplasia Ossificans Progressiva | 48 | 2021-12-24actual | — | 2022-08-03 |
| Study of VN-0200 in Japanese Healthy Adults and Elderly SubjectsNCT04914520Number of Participants Reporting Treatment-emergent Adverse EventsRandomized · Triple-masked · Prevention | Phase 1 | Completed | Biological: VN-0200, Placebo | Respiratory Syncytial Virus Infections | 48 | 2021-12-16actual | — | 2021-12-22 |
| Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac DiseaseNCT03395639results2022-07-26Number of Participants With Adjudicated Bleeding Events Within the Main Treatment PeriodRandomized · Open-label · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Edoxaban, Standard of Care (SOC) | Cardiac Disease | 168 | 2021-12-03actual | — | 2022-07-26 |
| DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)NCT04014075results2022-01-12Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) AdenocarcinomaOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Trastuzumab deruxtecan | Adenocarcinoma Gastric Stage IV With Metastases, Adenocarcinoma - GEJ | 79 | 2021-11-08actual | — | 2025-04-03 |
| Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) StudyNCT02303431results2023-10-11Pharmacokinetic Parameter of Apparent Systemic Clearance (CL/F)Non-randomized · Open-label · Basic scienceStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Edoxaban low dose, Edoxaban high dose | Deep Vein Thrombosis, Venous Thromboembolism | 66 | 2021-09-16actual | — | 2023-10-11 |
| Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast CancerNCT02980341results2024-08-13Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)Randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: Patritumab Deruxtecan | Metastatic Breast Cancer | 182 | 2021-08-16actual | — | 2024-10-30 |
| Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)NCT02668653results2022-10-05Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid LeukemiaRandomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Chemotherapy, Quizartinib, Placebo | Acute Myeloid Leukemia, Leukemia | 539 | 2021-08-13actual | — | 2024-08-06 |
| Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly SubjectsNCT04821674Number of Participants Reporting Treatment-emergent Adverse EventsRandomized · Triple-masked · Prevention | Phase 1/2 | Completed | Biological: DS-5670a, Placebo | Covid19 | 142 | 2021-08-13actual | — | 2022-08-30 |
| Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial CancerNCT03523572results2025-01-27Number of Participants With Dose-Limiting Toxicities at 3.2 mg/kg and 5.4 mg/kg Dose Level in Participants With HER2-expressing Advanced Breast Cancer in Dose EscalationNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Trastuzumab deruxtecan, Nivolumab | Breast Cancer, Urothelial Carcinoma | 86 | 2021-07-22actual | — | 2025-01-27 |
| A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic ImpairmentNCT04473664results2023-08-01Maximum Plasma Concentration (Cmax) of Quizartinib Following Single Dose of Quizartinib in Participants With Moderate Hepatic Impairment Compared to Participants With Normal Hepatic FunctionNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Quizartinib | Hepatic Impairment, Moderate Impaired Hepatic Function | 12 | 2021-07-22actual | — | 2023-08-01 |
| A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy SubjectsNCT04796831results2023-01-11Percentage of Absolute Oral Bioavailability for Quizartinib As Assessed By Pharmacokinetic Parameters for Area Under the Plasma Concentration-Time Curve Following Intravenous and Oral Administrations of QuizartinibOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Quizartinib dihydrochloride, 14C-Quizartinib solution for infusion | Healthy Subjects | 8 | 2021-06-11actual | — | 2023-01-11 |
| DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung CancerNCT03505710results2022-05-17Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Last participant transitioned to alternative study. | Drug: Trastuzumab deruxtecan | Non-Small Cell Lung Cancer | 181 | 2021-05-03actual | — | 2025-05-30 |
| Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/LymphomaNCT04102150Overall response rate (ORR) assessed by central evaluation organizationOpen-label · Treatment | Phase 2 | Completed | Drug: Valemetostat Tosylate | Adult T-cell Leukemia/Lymphoma | 25 | 2021-04-24actual | — | 2025-02-10 |
| Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)NCT03552029results2022-05-20Number of Participants With Dose Limiting Toxicities (DLTs) Following Administration of Milademetan in Combination With QuizartinibNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Terminatedsponsor's stated reason: This study was terminated based on a business decision by the Sponsor. | Drug: Quizartinib, Milademetan, Milademetan | Acute Myeloid Leukemia | 10 | 2021-04-01actual | — | 2022-05-20 |
| Tenosynovial Giant Cell Tumors (TGCT) Observational Platform ProjectNCT02948088results2023-10-31observationalNumber of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT)Study Protocol and Statistical Analysis Plan ↗ | — | Completed | — | Giant Cell Tumors | 183 | 2021-03-11actual | — | 2023-10-31 |
| DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)NCT03110354results2024-01-30Number of Participants With Any Grade Treatment-emergent Adverse Event Classified as Dose-limiting Toxicities (Dose Escalation)Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Terminatedsponsor's stated reason: This study was terminated due to slow accrual. | Drug: DS-3201b | Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Acute | 28 | 2021-03-09actual | — | 2024-01-31 |
| Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)NCT02943785results2022-03-24Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKARandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Edoxaban-based Regimen, VKA-based Regimen | Atrial Fibrillation | 1,426 | 2021-02-28actual | — | 2022-03-24 |
| Study of Single-dose DS-3201b in Participants With Hepatic ImpairmentNCT04276662Analysis of Pharmacokinetic Parameter: Maximum Concentration of DS-3201a (Cmax)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: DS-3201b | Hepatic Impairment | 28 | 2021-02-23actual | — | 2021-02-25 |
| Study of DS-1001b in Patients With Gene IDH1-Mutated GliomasNCT03030066Percentage of participants with dose limiting toxicitiesOpen-label · Treatment | Phase 1 | Completed | Drug: DS-1001b | Glioma | 47 | 2021-01-31actual | — | 2026-07-28 |
| Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)NCT04033094observationalQuarterly number of MorphaBond Extended Release (ER) dosage unit dispensed | — | Completed | Drug: MorphaBond ER, Comparator Drug | Baseline Epidemiologic Assessment | 17,566 | 2020-12-31actual | — | 2021-03-15 |
| Study of Mirogabalin for Central Neuropathic PainNCT03901352results2024-09-23Change From Baseline in the Weekly Average Daily Pain Score (ADPS) at Week 14 Following Administration With Mirogabalin or PlaceboRandomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Placebo, Mirogabalin | Central Neuropathic Pain | 300 | 2020-12-28actual | — | 2024-10-21 |
| Study of DS-5141b in Patients With Duchenne Muscular DystrophyNCT02667483results2024-03-07Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE) In Participants With Duchenne Muscular DystrophyOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: DS-5141b | Duchenne Muscular Dystrophy | 8 | 2020-10-20actual | — | 2024-03-07 |
| A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy ParticipantsNCT04459585results2021-07-09Maximum Plasma Concentration (Cmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant QuizartinibOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Early Phase 1 | Completed | Drug: Dabigatran Etexilate Mesylate, Quizartinib | Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, Quizartinib | 20 | 2020-10-20actual | — | 2021-07-09 |
| Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)NCT02951039observationalRate of Participants Experiencing Real-World Safety Data Events within 2 Years | — | Completed | Drug: Edoxaban | Atrial Fibrillation | 3,008 | 2020-10-15actual | — | 2021-01-12 |
| A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy ParticipantsNCT04459598results2022-06-06Maximum Plasma Concentration (Cmax) Following Single Dose of Quizartinib With or Without EfavirenzRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Efavirenz, Quizartinib | Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, Quizartinib | 32 | 2020-10-14actual | — | 2022-06-28 |
| A Multiple Ascending Dose Study of Milademetan in Subjects With Advanced Solid Tumors or LymphomasNCT01877382results2024-07-18Number of Participants With Treatment-emergent Adverse Events (≥10% Overall) in Participants Receiving MilademetanNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Milademetan, Milademetan | Advanced Solid Tumor, Lymphoma | 107 | 2020-10-08actual | — | 2025-03-27 |
| Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy ParticipantsNCT04223635results2021-06-07Maximum Plasma Concentration (Cmax) of Pexidartinib Following a Single Dose in Participants With Moderate Hepatic Impairment Compared to Healthy ParticipantsNon-randomized · Single-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Early Phase 1 | Completed | Drug: Pexidartinib | Moderate Hepatic Impairment | 16 | 2020-10-02actual | — | 2021-06-22 |
| DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung CancerNCT03255083results2022-01-11Number of Participants With Dose-limiting Toxicities (DLTs) Following Administration With DS-1205c in Combination With OsimertinibOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Terminatedsponsor's stated reason: This study was terminated based on a business decision by the Sponsor. | Drug: DS-1205c, Osimertinib | Non-small Cell Lung Cancer (NSCLC) | 13 | 2020-09-04actual | — | 2022-01-19 |
| Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)NCT02319369results2021-10-11Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Milademetan Alone and In Combination With 5-Azacitidine (AZA)Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Terminatedsponsor's stated reason: This study was terminated based on a business decision by the Sponsor. | Drug: Milademetan, AZA, Milademetan | Acute Myelogenous Leukemia, Myelodysplastic Syndrome | 74 | 2020-08-21actual | — | 2021-10-11 |
| DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung CancerNCT03599518results2023-02-08Number of Participants With Dose-limiting Toxicities (DLTs) Following Administration With DS-1205c in Combination With GefitinibOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Terminatedsponsor's stated reason: This study was terminated based on a business decision by the Sponsor. | Drug: DS-1205c, Gefitinib | Non Small Cell Lung Cancer | 20 | 2020-04-22actual | — | 2023-02-08 |
| Phase I Study of DS-2741a in Healthy Volunteers and Participants With Atopic DermatitisNCT04211415Incidence of adverse events among participants receiving DS-2741a (Part 1 and Part 3)Randomized · Quadruple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: Company decision of termination of the clinical program. | Drug: DS-2741a, Placebo | Atopic Dermatitis | 8 | 2020-03-14actual | — | 2021-06-22 |
| DS-9231 in Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)NCT03316729Percent change from baseline in total thrombus volumeRandomized · Double-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Product development cancelled. | Drug: DS-9231, Placebo | Pulmonary Embolism | 0 | Feb 2020 | — | 2018-12-24 |
| Safety of DS-1040b in Acute Ischemic Stroke Patients Treated With ThrombectomyNCT03198715results2021-01-28Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke ParticipantsRandomized · Single-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Drug: DS1040b, Placebo | Acute Ischemic Stroke | 42 | 2020-01-19actual | — | 2021-01-28 |
| Study of DU-176b Aged 80 Years or OlderNCT02801669results2020-11-19Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With PlaceboRandomized · Triple-masked · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Du-176b, placebo | Atrial Fibrillation | 984 | 2019-12-27actual | — | 2020-11-19 |
| DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]NCT03329690results2020-11-27Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)Randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: DS-8201a, Physician's Choice | Neoplasm, Gastrointestinal | 233 | 2019-11-08actual | — | 2022-03-18 |
| Colesevelam for Children With Type 2 DiabetesNCT01258075results2020-12-22Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6Randomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: High-dose colesevelam, Low-dose colesevelam | Type 2 Diabetes Mellitus | 236 | 2019-11-01actual | — | 2021-05-13 |
| Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Korea and Taiwan (ETNA-VTE-KOR-TWN)NCT02952599observationalRate of overall symptomatic VTE recurrence | — | Completed | Drug: Edoxaban | Venous Thromboembolism | 352 | 2019-10-29actual | — | 2019-12-23 |
| Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)NCT03671564results2023-11-07Number of Participants With Dose Limiting Toxicities (DLTs) Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid LeukemiaNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Milademetan | Acute Myeloid Leukemia | 14 | 2019-09-11actual | — | 2023-11-07 |
| Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic StrokeNCT02586233results2020-09-09Summary of Treatment-Emergent Adverse Event Reported by >10% of Participants Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic StrokeRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: DS-1040b, Placebo | Acute Ischemic Stroke, Thrombotic Disease | 106 | 2019-08-13actual | — | 2020-09-09 |
| DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)NCT03384940results2021-08-24Number of Participants With Best Objective Response Based on Independent Central Review (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal CancerNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: DS-8201a | Colorectal Neoplasm | 86 | 2019-08-09actual | — | 2021-10-18 |
| Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary EmbolismNCT02923115results2020-07-30Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary EmbolismRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: DS-1040b, Placebo, Enoxaparin | Pulmonary Embolism, Thrombotic Disease | 134 | 2019-08-05actual | — | 2023-04-19 |
| Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy VolunteersNCT03901313results2020-04-22Maximum Observed Concentration in Plasma (Cmax) of PexidartinibRandomized · Open-label · Basic scienceStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Treatment A - 400 mg Fasting, Treatment B - 400 mg Fed, Treatment C - 200 mg Fed | Healthy Volunteers | 24 | 2019-05-08actual | — | 2020-05-11 |
| A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)NCT03248492results2020-02-17Objective Response Rate as Confirmed by Independent Central Review Following Intravenous Administration of 5.4 mg/kg DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)Randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: The last participant was transitioned to alternative study. | Drug: DS-8201a | Breast Cancer | 253 | 2019-03-21actual | — | 2025-06-26 |
| Study of DS-8201a in Subjects With Advanced Solid Malignant TumorsNCT02564900results2021-06-23Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: DS-8201a (DP1), DS-8201a (DP2), DS-8201a (DP) | Advanced Solid Tumors | 292 | 2019-02-01actual | — | 2024-01-22 |
| DS2330b Alone and With Sevelamer in Patients on Chronic HemodialysisNCT03305471Part A, Period 1: Maximum concentration (Cmax) of DS-2330aRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DS-2330b PIB, Placebo, Sevelamer, DS-2330b Tablet | Hyperphosphatemia | 40 | 2019-01-03actual | — | 2019-03-25 |
| Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast CancerNCT03366428results2021-06-14Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast CancerOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: DS-8201a | Malignant Neoplasm of Breast | 51 | 2018-12-05actual | — | 2022-04-12 |
| Phase 1 Study of QuizartinibNCT02675478number of subjects experiencing adverse eventsOpen-label · Treatment | Phase 1 | Completed | Drug: AC220 | Relapsed AML, Refractory AML | 17 | 2018-11-13actual | — | 2019-02-12 |
| Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical OutcomesNCT02964949Pharmacokinetics: Average Concentration of Edoxaban at Steady State (Cav)Randomized · Triple-masked · Basic science | Not applicable | Completed | Drug: Edoxaban | Atrial Fibrillation | 607 | 2018-10-09actual | — | 2019-02-12 |
| Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy ParticipantsNCT03614455Maximum plasma concentration (Cmax) of milademetanRandomized · Open-label · Basic science | Early Phase 1 | Completed | Drug: Milademetan, Itraconazole, Posaconazole | Pharmacokinetics | 36 | 2018-10-01actual | — | 2019-02-12 |
| Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)NCT03291288results2020-03-19Pharmacokinetic Analysis: Maximum Concentration (Cmax) for MidazolamOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Tolbutamide, Midazolam, Pexidartinib | Drug Interaction Potential | 32 | 2018-09-26actual | — | 2021-05-14 |
| Study of DS-8201a for Participants With Advanced Solid Malignant TumorsNCT03383692results2021-06-14Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: DS-8201a, Ritonavir, Itraconazole | Neoplasm Metastasis | 40 | 2018-09-26actual | — | 2023-12-11 |
| Food Effects on Milademetan Pharmacokinetics in Healthy ParticipantsNCT03647202Maximum plasma concentration (Cmax) of milademetanRandomized · Open-label · Basic science | Early Phase 1 | Completed | Drug: Milademetan Treatment A, Milademetan Treatment B, Milademetan Treatment C | Food Effects on Pharmacokinetics | 18 | 2018-09-13actual | — | 2019-02-12 |
| A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated MelanomaNCT02975700results2020-04-09Summary of Best Overall Response Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated MelanomaOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Drug: PLX3397 | Melanoma | 6 | 2018-08-31actual | — | 2026-01-13 |
| A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid TumorsNCT02452424results2019-10-09Treatment-emergent Adverse Events (TEAEs) in Participants Regardless of Causality While Taking PLX3397 in Combination With PembrolizumabNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Terminated early for insufficient evidence of clinical efficacy | Drug: PLX3397 · Biological: Pembrolizumab | Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Gastrointestinal Stromal Tumor (GIST), Ovarian Cancer | 78 | 2018-08-17actual | — | 2020-03-05 |
| Edoxaban Management in Diagnostic and Therapeutic ProceduresNCT02950168observationalPercentage of participants with major bleeding within 30 days after a planned or unplanned procedure | — | Completed | Procedure: Edoxaban | Atrial Fibrillation, Venous Thromboembolism | 1,197 | 2018-07-26actual | — | 2020-02-05 |
| An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 DiabetesNCT05107063observationalPercentage Change Rate From Baseline in the Modification of Diet in Renal Disease(MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 24 After Routine Care of Pravastatin Administration | — | Completed | Drug: Pravastatin | Dyslipidemia Associated With Type II Diabetes Mellitus | 2,972 | 2018-04-19actual | — | 2021-11-04 |
| Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) MutationNCT02984995results2020-02-17Composite Complete Remission (CRc) Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Quizartinib | Leukemia, Myeloid, Acute | 37 | 2018-03-28actual | — | 2020-02-17 |
| (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD PositiveNCT02039726results2020-01-27Overall Survival in Participants That Received Quizartinib Versus Salvage ChemotherapyRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Quizartinib, Salvage Chemotherapy | AML | 367 | 2018-02-22actual | — | 2021-02-24 |
| Safety Study of PLX108-01 in Patients With Solid TumorsNCT01004861results2020-04-06Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population)Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: PLX3397 | Solid Tumor | 132 | 2018-01-31actual | — | 2022-01-04 |
| Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )NCT02633800results2019-01-07Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression PopulationRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Trial was terminated by sponsor due to lack of efficacy. | Drug: Patritumab, Cetuximab, Cisplatin, Carboplatin, Placebo | Head and Neck Neoplasms | 87 | 2018-01-11actual | — | 2019-01-07 |
| Study of DS-7080a for the Treatment of Macular DegenerationNCT02530918Number of participants experiencing any treatment-emergent adverse event (TEAE)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: DS-7080a, Ranibizumab | Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema | 56 | 2018-01-02actual | — | 2018-05-09 |
| Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid TumorsNCT01525602results2020-07-16Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population)Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: PLX3397, Paclitaxel | Solid Tumors | 74 | Dec 2017actual | — | 2020-07-16 |
| Study of DS-1123a in Advanced Solid TumoursNCT02690337Maximum concentration (Cmax)Open-label · Treatment | Phase 1 | Completed | Drug: DS-1123 | Advanced Solid Malignant Tumors | 27 | Nov 2017actual | — | 2018-12-24 |
| A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed GlioblastomaNCT01790503results2019-10-09Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose GroupNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: PLX3397, Temozolomide · Radiation: Radiation Therapy | Patients With Newly Diagnosed Glioblastoma | 65 | 2017-11-03actual | — | 2020-06-30 |
| Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)NCT02834390results2021-08-19Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Quizartinib, Cytarabine, Idarubicin, Daunorubicin | Acute Myeloid Leukemia | 7 | 2017-10-19actual | — | 2025-03-05 |
| Antibody DS-8273a Administered in Combination With Nivolumab in Subjects With Advanced Colorectal CancerNCT02991196Dose Escalation Part: Number of Participants with Dose-Limiting Toxicities (DLT)Open-label · Basic science | Phase 1 | Terminatedsponsor's stated reason: Business Decision | Drug: DS-8273a + nivolumab | Colorectal Neoplasm | 4 | 2017-09-22actual | — | 2019-02-12 |
| Cancer Venous Thromboembolism (VTE)NCT02073682results2018-10-24Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding EventRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Edoxaban, Dalteparin, Low molecular weight heparin | Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Cancer | 1,046 | 2017-09-15actual | — | 2019-03-06 |
| Study of CS-3150 in Patients With Primary AldosteronismNCT02885662Change from baseline in sitting blood pressureOpen-label · Treatment | Not applicable | Completed | Drug: CS-3150 | Primary Aldosteronism | 44 | 2017-07-20actual | — | 2018-12-21 |
| Study of CS-3150 in Patients With Essential HypertensionNCT02890173Change from baseline in sitting blood pressureRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: CS-3150, Eplerenone | Essential Hypertension | 1,001 | 2017-07-11actual | — | 2018-12-21 |
| Long-term Study of CS-3150 as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential HypertensionNCT02722265change from baseline in sitting systolic and diastolic blood pressureOpen-label · Treatment | Phase 3 | Completed | Drug: CS-3150 | Essential Hypertension | 368 | 2017-07-08actual | — | 2019-10-08 |
| Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney DiseaseNCT02496884results2020-10-12Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)Randomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: DS-5565, Placebo | Fibromyalgia | 56 | 2017-07-06actual | — | 2020-11-24 |
| DS-5565 Phase III Study for Diabetic Peripheral Neuropathic PainNCT02318706results2020-11-02Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic PainRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: DS-5565, placebo | Diabetic Peripheral Neuropathic Pain | 854 | 2017-06-29actual | — | 2020-11-02 |
| Study of Pexidartinib in Asian Subjects With Advanced Solid TumorsNCT02734433results2020-04-24Overall Response Based on RECIST V1.1 Following Oral Doses of Pexidartinib (Efficacy Analysis Set)Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Pexidartinib | Advanced Solid Tumors | 12 | 2017-06-13actual | — | 2022-04-25 |
| DS-5565 Phase III Study for Post-herpetic NeuralgiaNCT02318719results2020-11-02Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic NeuralgiaRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Drug: Placebo, DS-5565 | Post-Herpetic Neuralgia | 765 | 2017-05-25actual | — | 2020-11-02 |
| Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal ImpairmentNCT02807987Change from baseline in sitting systolic and diastolic blood pressureOpen-label · Treatment | Phase 3 | Completed | Drug: CS-3150 | Hypertension With Moderate Renal Impairment | 58 | 2017-05-15actual | — | 2018-12-21 |
| Study of CS-3150 Compared to Olmesartan in Patients With Essential HypertensionNCT02848170Change from baseline in 24 hr blood pressureRandomized · Open-label · Treatment | Not applicable | Completed | Drug: CS-3150, olmesartan medoxomil | Essential Hypertension | 40 | Apr 2017actual | — | 2018-12-21 |
| An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With FibromyalgiaNCT02234583results2020-07-23Average Daily Pain Score (ADPS) for DS-5565Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: DS-5565 | Pain Associated With Fibromyalgia | 2,485 | 2017-04-19actual | — | 2020-07-23 |
| DS-5565 Phase III Study for Renal Impairment in Japanese SubjectsNCT02607280results2020-10-26Change From Baseline in Average Daily Pain Score (ADPS) at Each WeekOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: DS-5565 | Diabetic Peripheral Neuropathic Pain, Post-herpetic Neuralgia | 35 | Mar 2017actual | — | 2021-05-13 |
| Study of CS-3150 in Hypertensive Patients With Type 2 Diabetes and AlbuminuriaNCT02807974Change from baseline in sitting systolic and diastolic blood pressureOpen-label · Treatment | Phase 3 | Completed | Drug: CS-3150 | Hypertension | 51 | Mar 2017actual | — | 2018-12-21 |
| Effect of Probenecid on Pexidartinib PharmacokineticsNCT03138759Maximum Plasma Concentration (Cmax)Randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Pexidartinib, Probenecid | Pharmacokinetics in Healthy Volunteers | 16 | 2017-03-30actual | — | 2017-05-03 |
| Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma (HCC) Who Have Been Treated With One Prior TherapyNCT01755767results2020-07-15Median Overall Survival (OS) Following Treatment With Tivantinib 120 mg BID Compared to Placebo Group in Participants With MET Diagnostic-High Inoperable Hepatocellular Carcinoma (HCC) Treated With One Prior Systemic TherapyRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Tivantinib, Placebo | Hepatocellular Carcinoma | 383 | 2017-03-28actual | — | 2021-04-06 |
| Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)NCT02371369results2020-01-10Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response to Pexidartinib Compared With That of Placebo Per Response Evaluation Criteria in Solid Tumors Version 1.1 at Week 25Randomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Pexidartinib, Placebo | Pigmented Villonodular Synovitis, Giant Cell Tumors of the Tendon Sheath, Tenosynovial Giant Cell Tumor | 120 | 2017-03-27actual | — | 2022-05-11 |
| Phase 1 Study of DS-8895a in Subjects With Advanced Solid TumorsNCT02004717number of participants experiencing dose limiting toxicitiesOpen-label · Treatment | Phase 1 | Completed | Drug: DS-8895a | Solid Tumors | 37 | Feb 2017actual | — | 2019-07-22 |
| An Open Study Assessing the Safety and Tolerability of U3-1784NCT02690350Number of Patients with Adverse EventsNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Program discontinued for business reasons (not safety). | Drug: U3-1784 | Advanced Solid Tumors, Hepatocellular Cancer (HCC) | 10 | 2017-02-28actual | — | 2018-05-16 |
| Study of CS-3150 in Patients With Severe HypertensionNCT02808026Change from baseline in sitting systolic and diastolic blood pressureOpen-label · Treatment | Phase 3 | Completed | Drug: CS-3150 | Severe Hypertension | 20 | Feb 2017actual | — | 2018-12-21 |
| Open Label Study of DS-5573aNCT02192567Number of subjects experiencing dose limiting toxicitiesOpen-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Business decision | Drug: DS-5573a | Advanced Solid Malignant Tumors | 19 | Jan 2017actual | — | 2017-03-03 |
| 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on MetforminNCT02647320results2018-05-01Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12Randomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Sitagliptin 100 mg, DS-8500a 25mg, Placebo Tablet, Placebo Capsule | Type 2 Diabetes Mellitus | 298 | 2017-01-31actual | — | 2019-02-25 |
| Study to Evaluate the Efficacy and Safety of DS-1971a for the Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)NCT02673866Change in weekly Average Daily Pain Score (ADPS)Randomized · Double-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: reassessment of phase 2 study indication | Drug: DS-1971a, placebo, pregabalin | Neuropathic Pain, Diabetes | 0 | Jan 2017 | — | 2016-07-27 |
| Treatment of Pain Associated With FibromyalgiaNCT02187471results2020-11-09Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) Among Participants Receiving DS-5565, Pregabalin, or PlaceboRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: DS-5565, Pregabalin, Placebo tablet, Placebo capsule | Pain Associated With Fibromyalgia | 1,301 | 2017-01-06actual | — | 2020-11-09 |
| Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)NCT02134015results2018-01-23Part A: Progression Free Survival (PFS) in Heregulin-high ParticipantsRandomized · Double-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Pre-defined criteria for continuation were not reached | Drug: Patritumab, Erlotinib, Placebo | Lung Cancer, Non-small Cell Lung Cancer | 145 | 2016-11-11actual | — | 2018-01-23 |
| A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)NCT02628392change in HbA1cRandomized · Quadruple-masked · Treatment | Not applicable | Completed | Drug: DS-8500a, Sitagliptin, placebo | Type2 Diabetes Mellitus | 368 | Sep 2016actual | — | 2019-02-12 |
| A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving SitagliptinNCT02685345change in 24 hour weighted mean glucoseRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: DS-8500a 25 mg, DS-8500a 75 mg, placebo | Type 2 Diabetes Mellitus | 85 | Sep 2016actual | — | 2019-02-12 |
| An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic ClampNCT02669732First-phase and Second-phase secretion InsulinRandomized · Quadruple-masked · Treatment | Not applicable | Completed | Drug: DS-8500a, placebo | Type 2 Diabetes Mellitus | 21 | Aug 2016actual | — | 2019-02-12 |
| Treatment of Pain Associated With FibromyalgiaNCT02146430results2020-11-09Change From Baseline in Weekly Average Daily Pain Score (ADPS) at Week 13 in Participants Receiving DS-5565, Pregabalin, PlaceboRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: DS-5565, Pregabalin, Placebo tablet, Placebo capsule | Pain Associated With Fibromyalgia | 1,293 | 2016-07-14actual | — | 2020-11-09 |
| Treatment of Pain Associated With FibromyalgiaNCT02187159results2020-11-09Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or PlaceboRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: DS-5565, Pregabalin, Placebo tablet, Placebo capsule | Pain Associated With Fibromyalgia | 1,270 | 2016-07-07actual | — | 2020-11-09 |
| A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With MicroalbuminuriaNCT02345057Change from baseline in urinary albumin to creatine ratio (UACR)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: CS-3150, placebo | Diabetic Nephropathy | 365 | Jun 2016actual | — | 2018-12-21 |
| Study of the Effects of Ethnicity on the Pharmacokinetics, Pharmacodynamics and Safety of DS-1040bNCT02647307Plasma concentrations of DS-1040Open-label · Basic science | Phase 1 | Completed | Drug: DS-1040b | Healthy | 48 | Jun 2016actual | — | 2018-12-24 |
| A Study to Determine the Effects of Itraconazole on the Pharmacokinetics (PK) of DS-8500 in Healthy SubjectsNCT02790671maximum concentration (Cmax) of DS-8500aOpen-label · Treatment | Phase 1 | Completed | Drug: DS-8500a, Itraconazole | Pharmacokinetics | 26 | Jun 2016actual | — | 2019-02-12 |
| A Study Assessing the Mass Balance of a Single Oral Dose of [14C] DS-8500a in Healthy SubjectsNCT02790684total 14C radioactivity in urine and fecesOpen-label · Other | Phase 1 | Completed | Drug: DS-8500a | Pharmacokinetics | 12 | Jun 2016actual | — | 2019-02-12 |
| Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute StrokeNCT02258880Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS)Randomized · Quadruple-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: study was stopped for business/administrative reasons and not for patient safety concerns | Drug: SUN13837, placebo | Stroke | 0 | May 2016 | — | 2015-10-20 |
| An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in Metastatic Colorectal Cancer (mCRC)NCT01039506observationalProgression free survival | — | Completed | Drug: CPT-11 based regimens | Metastatic Colorectal Cancer | 1,376 | 2016-04-28actual | — | 2019-05-29 |
| Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck CancerNCT02350712Percentage of participants experiencing dose-limiting toxicities (DLTs)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Patritumab, Cetuximab, Cisplatin, Carboplatin | Squamous Cell Carcinoma of the Head and Neck | 15 | Mar 2016actual | — | 2018-09-11 |
| Phase 1 Study to Evaluate the Safety and Tolerability of DS-1040b IV Infusion With Clopidogrel in Healthy SubjectsNCT02560688number of adverse eventsNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: DS-1040b, Clopidogrel | Drug Interaction | 22 | Mar 2016actual | — | 2018-12-24 |
| Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)NCT02072434results2019-03-13Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow upRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Edoxaban, Warfarin, Enoxaparin | Atrial Fibrillation | 2,199 | 2016-02-03actual | — | 2019-03-15 |
| AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) TreatmentNCT01973569results2019-12-13Change in Total Sharp Score (TSS) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or PlaceboRandomized · Quadruple-masked · Treatment | Not applicable | Completed | Drug: denosumab, placebo | Rheumatoid Arthritis | 679 | Dec 2015actual | — | 2020-02-12 |
| Open-label Study of DS-8273a to Assess Its Safety and Tolerability, and Assess Its Pharmacokinetic and Pharmacodynamic Properties in Subjects With Advanced Solid Tumors or LymphomasNCT02076451number of adverse eventsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: DS-8273a | Advanced Solid Tumor, Lymphoma | 32 | Dec 2015actual | — | 2019-02-12 |
| Pharmacokinetics of Tivantinib in Subjects With Advanced Solid Tumors and Hepatic ImpairmentNCT02150733Composite of plasma pharmacokinetic parameters of TivantinibNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Tivantinib, Tivantinib, Tivantinib, Tivantinib | Hepatic Impairment, Solid Tumor, Cancer | 29 | Dec 2015actual | — | 2019-02-12 |
| A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal ImpairmentNCT02448628Change from baseline in sitting systolic and diastolic blood pressureOpen-label · Treatment | Phase 2 | Completed | Drug: CS-3150 | Hypertension | 33 | Dec 2015actual | — | 2019-10-08 |
| Multiple Dose Study of D1971a in Healthy VolunteersNCT02564861Number of participants with at least one Treatment Emergent Adverse Event (TEAEs)Randomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: DS-1971a, Placebo | Healthy | 25 | Dec 2015actual | — | 2017-04-28 |
| The Effect of CS-3150 Exposure on Corrected QT (QTc) Interval Duration in Healthy VolunteersNCT04019652Change in corrected QT (QTc) interval from baseline following oral administration of 1 of 4 treatment sequences with CS-3150Randomized · Double-masked · Prevention | Phase 1 | Completed | Drug: CS-3150, Moxifloxacin, Placebo matching moxifloxacin tablet, Placebo matching CS-3150 | Hypertension, Mineralocorticoid Receptor Antagonist | 55 | 2015-12-23actual | — | 2019-07-15 |
| A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive SubjectsNCT02345044Change from baseline in sitting systolic and diastolic blood pressureRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: CS-3150, placebo, eplerenone | Essential Hypertension | 426 | Aug 2015actual | — | 2019-10-08 |
| A PHASE 1, OPEN-LABEL, CROSS-OVER, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF MULTIPLE DOSES OF DS-1971A ON THE SINGLE DOSE PHARMACOKINETICS OF PROBE SUBSTRATES FOR CYP2B6, CYP2C8, CYP2C9, CYP2C19 AND CYP3A4 ENZYMES IN HEALTHY MALE AND FEMALE SUBJECTSNCT02473627Pharmacokinetic profile for bupropionNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: DS-1971a, midazolam hydrochloride, Omeprazole, Pioglitazone hydrochloride, Buproprion, Tolbutamide | Healthy | 18 | Jul 2015actual | — | 2015-11-05 |
| Effect of Repeated Doses of DS-8500a on Pharmacokinetics of Rosuvastatin in Healthy VolunteersNCT03699774Maximum observed plasma drug concentration (Cmax) for single dose rosuvastatinOpen-label · Basic science | Phase 1 | Completed | Drug: DS-8500a, Rosuvastatin | Drug Pharmacokinetics in Healthy Volunteers | 24 | 2015-07-06actual | — | 2019-02-12 |
| Pilot PK/PD Study of DS-1093a in Patients With Chronic Kidney DiseaseNCT02299661Plasma concentrations of DS-1093aRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: DS-1093a | Chronic Renal Disease, Renal Anemia | 31 | May 2015actual | — | 2018-12-24 |
| A Study of AC220 Given After Transplant in Subjects With Acute Myeloid Leukemia (AML)NCT01468467Incidence of dose limiting toxicity (DLT)Open-label · Treatment | Phase 1 | Completed | Drug: AC220 | Leukemia, Myeloid, Acute | 13 | Mar 2015actual | — | 2019-02-12 |
| Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid LeukemiaNCT01565668results2019-12-27Number of Participants Who Achieved Composite Complete Response (CRc) (Intent-to-Treat Population)Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: AC220 | Leukemia, Myeloid, Acute | 76 | Mar 2015actual | — | 2019-12-27 |
| A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)NCT01390337Safety assessed by recording adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and laboratory assessmentsOpen-label · Treatment | Phase 1 | Completed | Drug: AC220, daunorubicin, cytarabine | Leukemia, Myeloid, Acute | 19 | Feb 2015actual | — | 2019-02-12 |
| Multiple Ascending Dose Study of DS-1093 in Healthy SubjectsNCT02142400blood concentration of DS-1093Randomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: DS-1093, placebo | Anaemia | 31 | Feb 2015actual | — | 2018-12-24 |
| Relative Bioavailability DS-1971a Suspension and Tablets and Food Effect on DS-1971a TabletsNCT02266940Pharmacokinetics profile of DS-1971aRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: DS-1971a suspension, DS-1971a tablet | Healthy | 18 | Jan 2015actual | — | 2018-12-24 |
| Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC)NCT01512199Determination of the maximum tolerated dose based on the incidence of dose limiting toxicities (phase 1b only)Randomized · Double-masked · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Improved, different standard of care caused business decision to terminate | Drug: U3-1287, Trastuzumab, Paclitaxel, U3-1287, Trastuzumab, Paclitaxel, Placebo | Metastatic Breast Cancer | 29 | 2015-01-28actual | — | 2017-10-18 |
| Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)NCT01349049results2019-11-21Summary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).Non-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: PLX3397, PLX3397 | Acute Myeloid Leukemia | 90 | 2015-01-20actual | — | 2020-03-02 |
| Edoxaban in Peripheral Arterial DiseaseNCT01802775results2018-01-12Percentage of Participants With Clinically Relevant Bleeding During TreatmentRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: edoxaban, Clopidogrel, Aspirin | Peripheral Arterial Disease | 203 | 2014-12-03actual | — | 2019-02-26 |
| Multiple Dose Study of DS-1971aNCT02190058adverse eventsRandomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: DS-1971a, placebo | Healthy | 32 | Nov 2014actual | — | 2018-12-24 |
| Phase 2 Study of DS-8500a in Patients With Type 2 DiabetesNCT02222350change in 24-hour weighted mean blood glucoseRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: 10mg DS-8500a tablet, 75mg DS-8500a tablet, placebo | Type 2 Diabetes Mellitus | 100 | Nov 2014actual | — | 2019-02-12 |
| Effects of Age, Gender & Race on the Pharmacokinetics (PK)of DS-1971aNCT02261376Pharmacokinetic (PK) Profile of DS-1971aNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: DS-1971a | Healthy | 48 | Nov 2014actual | — | 2018-12-24 |
| An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid TumorsNCT01040312observationalNumber of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues | — | Completed | Drug: CPT-11, Platinum analogues | Small Cell Lung Cancer, Non-small Cell Lung Cancer, Cervical Cancer, Ovarian Cancer, Gastric Cancer (Inoperable and Recurrent) | 321 | 2014-09-29actual | — | 2019-05-23 |
| A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF MelanomaNCT01826448results2020-05-28Percentage of Participants With Adverse Events Who Received PLX3397 in Combination With Vemurafenib in V600-mutated BRAF MelanomaNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: No activity was observed. BRAFi-naïve participants should have received triple combination treatment (including MEK inhibitor). Continuation was not justified. | Drug: PLX3397, vemurafenib | V600-mutated BRAF Unresectable Melanoma, V600-mutated BRAF Metastatic Melanoma, Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor | 13 | 2014-09-22actual | — | 2020-05-28 |
| Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)NCT01502631results2021-01-15Total Spinal Cord Independence Measure, Version III (SCIM III) Score Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord InjuryRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: SUN13837 injection, Placebo | Acute Spinal Cord Injury | 65 | 2014-09-21actual | — | 2021-01-15 |
| Single Ascending Dose Study Using DS-1971 to Assess Safety, Tolerability, and Pharmacokinetics in Healthy Participants.NCT02107885safety and tolerability adverse eventsRandomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: DS-1971, placebo | Safety, Tolerability, Pharmacokinetics | 64 | Jul 2014actual | — | 2018-12-24 |
| A Open-Label, Multiple Ascending Dose Study of DS-3078a, an Oral TORC1/2 Kinase Inhibitor, in Subjects With Advanced Solid Tumors or LymphomasNCT01588678Maximum tolerated doseOpen-label · Treatment | Phase 1 | Completed | Drug: DS-3078a | Advanced Solid Tumor, Lymphoma | 32 | Jun 2014actual | — | 2019-02-12 |
| Randomized, Placebo-controlled, 2 Period, Single-blind, Sequential, Multiple Ascending Dose StudyNCT01956305safety and tolerability of DS-7309Randomized · Single-masked · Treatment | Phase 1 | Completed | Drug: DS-7309, placebo, Metformin | Type 2 Diabetes Mellitus | 48 | Jun 2014actual | — | 2014-11-24 |
| A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on AnticoagulationNCT02047565Bleeding duration 60mg edoxabanRandomized · Double-masked · Supportive care | Phase 1 | Completed | Drug: 60mg edoxaban, 180mg edoxaban, 50 IU/kg Beriplex P/N, 25 IU/kg Beriplex P/N, 10 IU/kg Beriplex P/N | Bleeding | 110 | May 2014actual | — | 2019-02-12 |
| DS1040b/Aspirin Drug/Drug Interaction StudyNCT02071004bleeding timeNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: DS-1040b, Aspirin | Acute Ischemic Stroke | 18 | Feb 2014actual | — | 2018-12-24 |
| A Study of DS-2248 in Participants With Advanced Solid TumorsNCT01288430results2020-07-10Summary of Objective Response Rate Following Oral Administration of DS-2248 in Participants With Advanced Solid TumorsNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: The trial was terminated as per Sponsor decision. | Drug: DS-2248 | Solid Tumors, Non-small Cell Lung Carcinoma | 60 | 2014-02-13actual | — | 2021-10-05 |
| A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein ThrombosisNCT01662908results2017-05-12Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method]Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: edoxaban tosylate, enoxaparin/unfractionated heparin, warfarin | Deep Vein Thrombosis, Venous Thrombosis | 85 | Jan 2014actual | — | 2019-02-26 |
| Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic DermatitisNCT01756898results2021-02-16Number of Investigator's Global Assessment (IGA) Responders at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic DermatitisRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: 5 mg ASB17061, Placebo, 10 mg ASB17061, 20 mg ASB17061 | Atopic Dermatitis | 370 | 2014-01-14actual | — | 2021-02-16 |
| Safety and Tolerability of DS-7423 in Subjects With Advanced Solid Malignant TumorsNCT01364844Adverse EventsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: DS-7423 | Solid Tumor, Colorectal Cancer, Endometrial Cancer | 42 | Nov 2013actual | — | 2014-02-25 |
| A Phase 2 Study of PLX3397 in Patients With Recurrent GlioblastomaNCT01349036results2020-01-09Summary of Response Rates in Participants on Treatment With PLX3397Non-randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Business Decision | Drug: PLX3397 | Recurrent Glioblastoma | 38 | 2013-11-05actual | — | 2020-03-03 |
| Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung CancerNCT01211483results2021-06-16Progression-Free Survival Following U3-1287 (AMG 888) in Combination With ErlotinibRandomized · Quadruple-masked · Treatment | Phase 1/2 | Completed | Drug: U3-1287, Erlotinib, Placebo | NSCLC (Advanced Non-small Cell Lung Cancer) | 222 | Oct 2013actual | — | 2021-06-16 |
| Study to Assess Pharmacokinetics, Immunogenicity and Safety/Tolerability of Patritumab (U3-1287)NCT01957280AUC (0-21 day) of PatritumabOpen-label · Treatment | Phase 1 | Completed | Drug: patritumab | Solid Tumors | 17 | Oct 2013actual | — | 2014-05-14 |
| Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DS-1150b in Healthy Subjects and Subjects With Type-2 Diabetes MellitusNCT02004678area under curve (AUC)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DS-1150b · Other: Placebo | Type 2 Diabetes Mellitus | 40 | Sep 2013actual | — | 2018-12-24 |
| Drug-drug Interaction Study of Tivantinib (ARQ 197) With Omeprazole, S-warfarin, Caffeine, Midazolam, and Digoxin in Cancer SubjectsNCT01517399Area under the plasma concentration versus time curve (AUC) for S-Warfarin, Caffeine, Midazolam and DigoxinOpen-label · Other | Phase 1 | Completed | Drug: tivantinib, omeprazole, s-warfarin, caffeine, digoxin, midazolam · Dietary supplement: vitamin K | Solid Tumors | 28 | Aug 2013actual | — | 2019-02-12 |
| Study of CS-1008 in Combination With FOLFIRI in Patients Who Have Failed Other TreatmentsNCT01124630Objective Response RateOpen-label · Treatment | Phase 1 | Completed | Drug: CS-1008, FOLFIRI | Metastatic Colorectal Cancer | 21 | Jul 2013actual | — | 2013-12-03 |
| Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral NeuropathyNCT01504412results2020-03-18Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral NeuropathyRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: DS-5565, DS-5565, DS-5565, Placebo, Pregabalin capsules | Pain, Diabetic Peripheral Neuropathy | 450 | Jun 2013actual | — | 2020-03-18 |
| Observational Study to Evaluate the Simplified-STroke REhabilitation Assessment of Movement (S-STREAM) Scale in Subjects Who Have Experienced a Nonhemorrhagic Ischemic StrokeNCT01496885results2021-02-03observationalMean Change From Baseline in Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke | — | Completed | Other: Observational study | Nonhemorrhagic Ischemic Stroke, Motor Function | 120 | 2013-05-22actual | — | 2021-02-03 |
| Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial FibrillationNCT00781391results2015-03-25Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).Randomized · Quadruple-masked · Prevention | Phase 3 | Completed | Drug: warfarin tablets, Edoxaban tablets (high dose regimen-60mg), Edoxaban tablets (low dose regimen-30mg), placebo warfarin, placebo edoxaban | Stroke, Atrial Fibrillation, Embolism | 21,105 | Apr 2013actual | — | 2019-03-05 |
| Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line TherapyNCT00967616results2020-05-04Percentage of Participants With Progression-Free Survival at 16 Weeks After Administration of CS-7017 Combined With Irinotecan, Leucovorin, and 5-Fluorouracil (5-FU) After Failure of First-line Therapy in Treatment of Metastatic Colorectal CancerRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: CS7017, irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI) | Colorectal Cancer, Neoplasms, Colorectal | 100 | Apr 2013actual | — | 2020-05-04 |
| Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).NCT00986154results2015-02-25Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PERandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: edoxaban tosylate(DU-176b), low molecular weight heparin/unfractionated heparin, warfarin | Venous Thromboembolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Thromboembolism, Venous Thrombosis | 8,292 | Apr 2013actual | — | 2019-03-05 |
| Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung CancerNCT01101334results2020-06-16Summary of Analysis of Progression-Free Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line TherapyRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: CS-7017, erlotinib | Advanced Non-small Cell Lung Cancer (NSCLC) | 90 | Apr 2013actual | — | 2020-06-16 |
| Safety Study for Intravenous (IV) AC480 (AC480IV) to Treat Advanced Solid TumorsNCT01245543Determine the safety and tolerability, including the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD), of a 2-day pulse of AC480IV both as monotherapy and in combination with docetaxel in patients with advanced solid tumor malignancies.Non-randomized · Open-label · Treatment | Phase 1 | Withdrawnsponsor's stated reason: Clinical investigations have been discontinued and transfer to BMS 3/24/2015 | Drug: AC480IV, Docetaxel | Solid Tumors | 0 | Mar 2013actual | — | 2015-11-02 |
| Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)NCT01499043results2019-10-18Summary of High Circulating Tumor Cell Count Number In Men With Radiographically Progressive Castration-Resistant Prostate Cancer and High Circulating Tumor CellsOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Business decision. | Drug: PLX3397 | Prostate Cancer | 6 | 2013-03-11actual | — | 2020-03-04 |
| Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery DiseaseNCT01587651results2014-04-29P2Y12 Reaction UnitsRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: Prasugrel Loading Dose, Prasugrel Maintenance Dose, Ticagrelor Maintenance Dose | Coronary Artery Disease | 110 | Feb 2013actual | — | 2019-01-09 |
| Study to Assess the Safety and Tolerability of U3-1565 in Subjects With Advanced Solid Malignant TumorsNCT01290471Number (percent) of subjects experiencing adverse events (AEs) after treatment with U3-1565Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: U3-1565 | Advanced Solid Malignant Tumors, Advanced Ovarian Cancer | 36 | Jan 2013actual | — | 2014-05-19 |
| Effect of Tivantinib on the QTC Interval in Cancer SubjectsNCT01699061The time-matched difference in the QTcF interval at each timepoint after both single and multiple doses of tivantinib compared with placeboNon-randomized · Single-masked · Treatment | Phase 1 | Completed | Drug: Tivantinib, Placebo | Solid Tumors | 38 | Jan 2013actual | — | 2019-02-12 |
| Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal ImpairmentNCT01857622results2015-01-26Incidence of Any Adjudicated Bleeding EventsRandomized · Open-label · Prevention | Phase 3 | Completed | Drug: DU-176b 15mg, DU-176b 30mg, DU-176b 60mg | Non-valvular Atrial Fibrillation | 93 | Jan 2013actual | — | 2019-03-05 |
| Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower LimbsNCT01857583results2015-01-26Incidence of Any Adjudicated Bleeding EventsRandomized · Open-label · Prevention | Phase 3 | Completed | Drug: 15mg DU-176b, 30mg DU-176b, Fondaparinux | Venous Thromboembolism | 80 | Dec 2012actual | — | 2019-03-05 |
| Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung CancerNCT01244191results2020-10-30Overall Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung CancerRandomized · Triple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Sponsor decision due to the protocol-defined stopping boundary for futility was met based on the interim OS data. | Drug: Tivantinib, Placebo, Erlotinib | Non Squamous, Non-small-cell Lung Cancer | 1,048 | 2012-12-15actual | — | 2021-04-06 |
| Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line ChemotherapyNCT00986440results2020-11-05Percentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line ChemotherapyRandomized · Triple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Due to changes to the standard of care within the proposed market for CS-7017. | Drug: CS-7017, Placebo | Colorectal Cancer | 84 | 2012-10-29actual | — | 2020-11-05 |
| ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal CancerNCT01075048results2020-08-14Progression-Free Survival (PFS) Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Participants With Metastatic Colorectal Cancer With Wild-Type K-ras Oncogene (KRAS) Who Have Received Front-Line Systemic TherapyRandomized · Double-masked · Treatment | Phase 1/2 | Completed | Drug: Tivantinib, Placebo, Cetuximab, Irinotecan | Metastatic Colorectal Cancer | 131 | 2012-10-12actual | — | 2021-04-08 |
| Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)NCT00989261results2019-11-29Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [+] Participants)Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Compound AC220 | Acute Myeloid Leukemia | 333 | 2012-09-28actual | — | 2019-12-11 |
| Treatment of Neuropathic Pain Associated With Diabetic Peripheral NeuropathyNCT01496365results2021-01-05Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and PlaceboRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: DS-5565 tablet, pregabalin capsule, Placebo tablet, placebo capsule | Diabetic Peripheral Neuropathy | 452 | 2012-09-07actual | — | 2021-01-05 |
| Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes MellitusNCT00789750results2017-06-26Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Colesevelam, Placebo, Pioglitazone | Type 2 Diabetes Mellitus | 562 | Jul 2012actual | — | 2017-06-26 |
| CS1008- in Combination With Sorafenib Compared to Sorafenib Alone in Subjects With Advanced Liver CancerNCT01033240results2021-04-08Time to Progression (TTP) Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver CancerRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: CS-1008 2 mg/kg, Sorafenib, CS-1008 6/2 mg/kg, CS-1008 6/6 mg/kg, CS-1008 4 mg/kg, CS-1008 6 mg/kg | Advanced Hepatocellular Carcinoma, Liver Cancer, Hepatic Cancer, Liver Neoplasms | 172 | 2012-07-13actual | — | 2021-04-08 |
| Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With OsteoporosisNCT00680953results2014-02-26Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to PlaceboRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Denosumab, Placebo, Alendronate sodium hydrate | Osteoporosis | 1,262 | Jun 2012actual | — | 2015-03-12 |
| Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin LymphomaNCT01217229results2013-03-15Progression-Free Survival According to the Cheson Criteria by Kaplan-Meier Analysis Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)Open-label · Treatment | Phase 2 | Completed | Drug: PLX3397 | Hodgkin Lymphoma | 20 | 2012-04-26actual | — | 2020-06-30 |
| Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung CancerNCT00806286results2020-05-13Percentage of Participants With Progression-Free Survival at 18 Weeks Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung CancerRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: CS7017 tablets, Paclitaxel, Carboplatin, Placebo Tablets | Metastatic Non-small Cell Lung Cancer | 111 | Jan 2012actual | — | 2020-05-13 |
| A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With PaclitaxelNCT00603941results2020-09-16Overall Progression-free Survival in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC)Non-randomized · Open-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Due to low enrollment, no participant had a dose limiting toxicity, therefore a maximum tolerated dose could not be established | Drug: CS-7017, Paclitaxel | Anaplastic Thyroid Cancer | 19 | Dec 2011actual | — | 2020-09-16 |
| Welchol as Monotherapy for Type 2 Diabetes MellitusNCT00789737results2014-01-22Percent Change in Hemoglobin A1cRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Welchol, Placebo | Type 2 Diabetes Mellitus | 357 | Dec 2011actual | — | 2014-02-27 |
| CS-1008 Used With Irinotecan Versus Irinotecan Alone in Subjects With Metastatic Colorectal Carcinoma Who Failed First-line Treatment With OxaliplatinNCT00969033Determine the difference in progression-free survival (PFS) for CS-1008 administered in combination with irinotecan and irinotecan alone.Randomized · Open-label · Treatment | Phase 2 | Terminated | Drug: CS-1008, irinotecan | Metastatic Colorectal Cancer | 8 | Dec 2011actual | — | 2012-01-31 |
| CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)NCT01199068results2020-07-31CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line TherapyOpen-label · Treatment | Phase 1 | Completed | Drug: CS-7017, Erlotinib | Carcinoma, Non-Small-Cell Lung | 15 | Dec 2011actual | — | 2021-05-13 |
| Dose Finding, Safety and Tolerability Study for AC220 to Treat Advanced Solid TumorsNCT01049893Safety and tolerability of AC220 given once daily without food continuously for 28 days (1 cycle) to patients with advanced solid tumors.Open-label · Treatment | Phase 1 | Completed | Drug: Compound AC220 | Solid Tumors | 45 | Nov 2011actual | — | 2019-02-12 |
| ARQ 197 for Participants With Relapsed or Refractory Germ Cell TumorsNCT01055067results2020-09-09Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell TumorsOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: The study was terminated early for futility according to the stopping rule of the Simon 2-stage design. | Drug: Tivantinib (ARQ 197) | Non-CNS Germ Cell Tumors (Seminomas and Nonseminomas) | 27 | 2011-11-30actual | — | 2021-04-06 |
| The Influence of Smoking Status on Prasugrel and Clopidogrel Treated Subjects Taking Aspirin and Having Stable Coronary Artery DiseaseNCT01260584results2012-12-12Inhibition of Platelet Aggregation (IPA) in Prasugrel-treated and Clopidogrel-treated Smokers and Non-smokers Following 9 Days of Maintenance Therapy.Randomized · Triple-masked · Treatment | Phase 4 | Completed | Drug: Prasugrel, Clopidogrel | Coronary Artery Disease | 110 | Sep 2011actual | — | 2019-01-09 |
| A Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS-7309 in Healthy Volunteers and Subjects With Type 2 Diabetes MellitusNCT01862939incremental area under the curve (IAUC) blood glucoseRandomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: DS-7309, placebo | Type 2 Diabetes Mellitus | 52 | Sep 2011actual | — | 2013-05-27 |
| Combination Chemotherapy With CS-1008 to Treat Ovarian CancerNCT00945191results2020-11-18Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian CancerOpen-label · Treatment | Phase 2 | Completed | Drug: CS-1008, Paclitaxel, Carboplatin | Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV | 24 | 2011-08-23actual | — | 2021-04-08 |
| CS-1008 With Carboplatin/Paclitaxel in Chemotherapy naïve Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer (NSCLC)NCT00991796Difference in progression-free survival (PFS) of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatinRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: CS-1008, Placebo, Paclitaxel, Carboplatin | Non-small Cell Lung Cancer | 109 | Jul 2011actual | — | 2012-09-10 |
| Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral Doses for AC430 in Healthy SubjectsNCT01287858Assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: AC430 | Rheumatoid Arthritis | 88 | Jun 2011actual | — | 2015-11-02 |
| CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)NCT01199055results2020-07-07Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung CancerOpen-label · Treatment | Phase 1 | Completed | Drug: CS-7017, Carboplatin, Paclitaxel | Carcinoma, Non-Small-Cell Lung | 16 | Apr 2011actual | — | 2020-07-07 |
| Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017NCT00881569results2020-08-14Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With CancerOpen-label · Treatment | Phase 1 | Completed | Drug: CS-7017 | Advanced Cancer | 2 | Mar 2011actual | — | 2020-09-28 |
| Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid TumorsNCT01149720Determination of the relative bioavailability of ARQ 197 tablet formulation with capsule C formulationRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Tivantinib (ARQ 197) Capsule, Tivantinib (ARQ 197) Tablet, Tivantinib (ARQ 197) Capsule D, oral | Solid Tumors | 24 | Mar 2011actual | — | 2019-02-12 |
| Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in HypertensionNCT00923091results2012-04-06Change in Seated Diastolic Blood Pressure (SeDBP).Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo, Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo, olmesartan medoxomil + amlodipine + hydroclororthiazide, olmesartan medoxomil + amlodipine + hydroclororthiazide, olmesartan medoxomil + amlodipine + hydroclororthiazide, olmesartan medoxomil + amlodipine, olmesartan medoxomil + amlodipine, olmesartan medoxomil + amlodipine | Essential Hypertension | 2,689 | Jan 2011actual | — | 2019-01-10 |
| 12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis PatientsNCT00616733Safety and tolerability.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CS-0777 tablets, CS-0777 tablets, CS-0777 tablets | Multiple Sclerosis | 25 | Sep 2010actual | — | 2011-03-10 |
| Hydrochlorothiazide as add-on to Olmesartan/Amlodipine in HypertensionNCT00902538results2011-11-22Change in Seated Diastolic Blood Pressure (SeDBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mgRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Olmesartan medoxomil 40 mg - Amlodipine 10 mg, Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg, Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg, OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg, OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg, OLM 40mg-AML 10mg-Hydrochlorothiazide 25mg | Essential Hypertension | 2,204 | Sep 2010actual | — | 2019-01-11 |
| Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic CancerNCT00521404results2020-12-03Progression-Free Survival Rate at 16 Weeks Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic CancerOpen-label · Treatment | Phase 2 | Completed | Drug: CS-1008 (humanized anti-DR5 antibody), gemcitabine | Pancreatic Cancer | 65 | 2010-08-20actual | — | 2021-04-08 |
| Prasugrel/Clopidogrel Maintenance Dose Washout StudyNCT01014624results2011-09-09The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to BaselineRandomized · Triple-masked · Treatment | Phase 4 | Completed | Drug: Prasugrel, Clopidogrel | Coronary Artery Disease | 56 | May 2010actual | — | 2021-06-28 |
| Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic CancerNCT00408434results2020-10-19Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic MalignanciesOpen-label · Treatment | Phase 1 | Completed | Drug: CS-7017 | Neoplasm | 32 | Feb 2010actual | — | 2020-10-19 |
| Olmesartan Comparison to Losartan in Hypertensive SubjectsNCT00949884results2011-02-28Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: olmesartan medoxomil, Placebo, losartan potassium | Hypertension | 941 | Jan 2010actual | — | 2011-03-09 |
| A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip ArthroplastyNCT01181167results2015-01-26Incidence of Subjects With Venous Thromboembolism EventsRandomized · Quadruple-masked · Prevention | Phase 3 | Completed | Drug: edoxaban, enoxaparin sodium | Prevention, Venous Thromboembolism | 610 | Jan 2010actual | — | 2019-03-05 |
| SUN11031 in Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)NCT00698828results2021-01-28Mean Change From Baseline to Day 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Placebo comparator, SUN11031 20 μg/kg, SUN11031 40 μg/kg | Cachexia | 227 | 2009-10-08actual | — | 2021-01-28 |
| A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee ArthroplastyNCT01181102results2015-02-19Incidence of Subjects With Venous Thromboembolism Events.Randomized · Quadruple-masked · Prevention | Phase 3 | Completed | Drug: edoxaban, enoxaparin sodium | Venous Thromboembolism | 716 | Sep 2009actual | — | 2019-03-05 |
| A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood PressureNCT00791258results2010-09-29The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 WeeksOpen-label · Treatment | Phase 4 | Completed | Drug: amlodipine and olmesartan medoxomil tablets, hydrochlorothiazide tablets | Hypertension | 999 | Aug 2009actual | — | 2019-01-09 |
| Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture SurgeryNCT01181141results2015-01-26The Incidence of Major or Clinically Relevant Non-major BleedingRandomized · Open-label · Prevention | Phase 3 | Completed | Drug: DU-176b (edoxaban), Enoxaparin sodium 20mg | Venous Thromboembolism | 92 | Aug 2009actual | — | 2019-03-05 |
| Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.NCT00570739results2010-07-13Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects.Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Metformin HCl and Colesevelam Placebo, Metformin HCl tablets and Colesevelam tablets, Colesevelam placebo, Colesevelam | Type 2 Diabetes Mellitus, Hypercholesterolemia, Pre-diabetes | 502 | Apr 2009actual | — | 2010-07-27 |
| Safety and Efficacy Study of a Triple Combination Therapy in Subjects With HypertensionNCT00649389results2010-09-01Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Olmesartan medoxomil, Amlodipine, Hydrochlorothiazide | Hypertension | 2,500 | Apr 2009actual | — | 2019-01-09 |
| 18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 DiabeticsNCT00654745results2010-07-02Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active TreatmentNon-randomized · Open-label · Treatment | Phase 4 | Completed | Drug: Amlodipine, amlodipine / olmesartan medoxomil combination, Hydrochlorothiazide | Type 2 Diabetes, Hypertension | 207 | Apr 2009actual | — | 2010-07-13 |
| A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic DermatitisNCT00717769results2021-04-21Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic DermatitisRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: SUN13834, Placebo | Atopic Dermatitis | 270 | 2009-04-09actual | — | 2021-04-21 |
| A Phase I Study of AC220 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Regardless of FLT3 StatusNCT00462761results2020-04-24Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid LeukemiaOpen-label · Treatment | Phase 1 | Completed | Drug: AC220 | Acute Myeloid Leukemia, Leukemia, Myelodysplastic Syndrome, AML, MDS | 76 | Mar 2009actual | — | 2020-05-11 |
| A Multinational Phase III Study of CS-8958 (MARVEL)NCT00803595results2011-11-22Time to Alleviation of Influenza IllnessRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: CS-8958, CS-8958, oseltamivir phosphate | Influenza, Human | 1,002 | Mar 2009actual | — | 2019-01-09 |
| Study of Rivoglitazone in Type 2 Diabetes MellitusNCT00484198results2021-07-27Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes MellitusRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Pioglitazone, Placebo, Rivoglitazone, Rivoglitazone | Type 2 Diabetes Mellitus | 1,912 | 2009-02-12actual | — | 2021-07-27 |
| Effects of Multiple Doses of CS-8080 in Healthy VolunteersNCT00796575SafetyRandomized · Double-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: Safety concerns | Drug: CS-8080, placebo tablets, CS-8080, CS-8080 | Healthy | 16 | Dec 2008actual | — | 2018-12-21 |
| A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip ArthroplastyNCT01203098results2015-02-09Percentage of Subjects With Venous Thromboembolism EventsRandomized · Quadruple-masked · Prevention | Phase 2 | Completed | Drug: DU-176b 15mg, DU-176b 30mg, Enoxaparin sodium 20 mg (=2000IU) | Venous Thromboembolism, Thromboembolism, Thrombosis, Embolism and Thrombosis, Deep Vein Thrombosis, Arthroplasty, Replacement, Hip | 264 | Dec 2008actual | — | 2019-02-25 |
| DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial FibrillationNCT00806624results2015-01-26Incidence of All BleedingRandomized · Quadruple-masked · Prevention | Phase 2 | Completed | Drug: DU-176b tablets, DU-176b tablets, Warfarin tablets | Atrial Fibrillation, Stroke | 234 | Oct 2008actual | — | 2019-02-26 |
| Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood PressureNCT00151775results2010-04-02Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)Randomized · Double-masked · Treatment | Phase 2/3 | Completed | Drug: olmesartan medoxomil, placebo, olmesartan medoxomil | Hypertension | 362 | Sep 2008actual | — | 2016-06-30 |
| ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy TrialNCT00141453results2011-05-10Renal Composite OutcomesRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: olmesartan medoxomil, Placebo Tablets | Diabetic Nephropathy, Type 2 Diabetes Mellitus, Proteinuria | 577 | Aug 2008actual | — | 2011-05-10 |
| Effects of CS-8080 in Healthy VolunteersNCT00613431Safety assessed over the 5-day post-dose inpatient period and at a follow-up 1 week post-discharge.Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: CS8080, Placebo | Healthy | 72 | Aug 2008actual | — | 2018-12-21 |
| Late Phase 2 Study of DU-176b in Patients With Non-Valvular Atrial FibrillationNCT00829933results2015-01-26Incidence of Bleeding Events (Major Bleeding, Clinically Relevant Non-major Bleeding and Minor Bleeding ) Identified During the Period From the Entry Into the Treatment Period Until Completion or Termination of the Treatment.Randomized · Quadruple-masked · Prevention | Phase 2 | Completed | Drug: DU-176b tablets, Warfarin potassium tablets | Atrial Fibrillation | 536 | Jul 2008actual | — | 2019-02-25 |
| Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's DiseaseNCT00623363results2021-03-11Change From Baseline in the Percentage of "On" Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a PlaceboRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: piclozotan, 0.9% sodium chloride (normal saline) | Parkinson's Disease | 27 | 2008-07-17actual | — | 2021-03-11 |
| A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial FibrillationNCT00504556results2015-03-13Adjudicated Incidence of Bleeding EventsRandomized · Double-masked · Prevention | Phase 2 | Completed | Drug: Edoxaban (DU-176b), Edoxaban (DU-176b), Edoxaban (DU-176b), Edoxaban (DU-176b), warfarin | Atrial Fibrillation, Thromboembolism | 1,146 | Jun 2008actual | — | 2019-02-26 |
| Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 DiabetesNCT00575874Change in HbA1c from baseline for rivoglitazone HCl compared to that for placeboRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Rivoglitazone HCl, rivoglitazone HCl, rivoglitazone HCl, pioglitazone HCl, placebo | Type 2 Diabetes | 150 | Jun 2008actual | — | 2009-02-09 |
| Combination of Olmesartan and Hydrochlorothiazide in Essential HypertensionNCT00430950results2009-04-20Change in Mean Trough Sitting Diastolic Blood PressureRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets, olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg | Essential Hypertension | 1,011 | May 2008actual | — | 2019-01-10 |
| Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes MellitusNCT00571519results2021-02-26Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes MellitusRandomized · Double-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: DSPD focusing on Study 301 to confirm the clinical profile before proceeding. Daiichi Sankyo Pharma Development terminated this study on 23 Apr 2008 because of changes in the clinical development plan with 94 of 2600 planned, randomized participants. | Drug: Rivoglitazone HCl, rivoglitazone HCl, rivoglitazone HCl, placebo, pioglitazone HCl, pioglitazone HCl, pioglitazone HCl 45 mg, placebo, metformin | Type 2 Diabetes Mellitus | 94 | 2008-05-23actual | — | 2021-05-26 |
| An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With HypertensionNCT00412932results2009-09-11Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active TreatmentNon-randomized · Open-label · Treatment | Phase 4 | Completed | Drug: Olmesartan medoxomil, Olmesartan medoxomil/hydrochlorothiazide | Hypertension | 178 | Apr 2008actual | — | 2009-09-22 |
| Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With MetforminNCT00484419results2009-06-17Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 EndpointRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Colesevelam HCl, rosiglitazone maleate, sitagliptin phosphate | Type 2 Diabetes, Hyperlipidemia | 169 | Apr 2008actual | — | 2016-10-04 |
| Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II HypertensionNCT00527514results2009-09-23Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory MonitoringNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Amlodipine, Olmesartan medoxomil plus amlodipine | Hypertension | 185 | Apr 2008actual | — | 2009-11-11 |
| Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential HypertensionNCT00430508results2009-06-17Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo, olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets, olmesartan medoxomil/hydrochlorothiazide tablets, olmesartan medoxomil/hydrochlorothiazide tablets | Essential Hypertension | 972 | Mar 2008actual | — | 2019-01-09 |
| Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 DiabetesNCT00575471Change in HbA1c from baseline for rivoglitazone compared to placeboRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Rivoglitazone HCl, rivoglitazone HCl, rivoglitazone HCl, Placebo | Type 2 Diabetes | 250 | Mar 2008actual | — | 2009-03-02 |
| Olmesartan Pediatric Pharmacokinetic (PK) StudyNCT00151814results2010-04-09For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Olmesartan medoxomil | Hypertension | 24 | Feb 2008actual | — | 2010-04-15 |
| Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 DiabetesNCT00147745results2009-12-04Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Colesevelam, Colesevelam matching placebo, Insulin glargine (Lantus) | Type 2 Diabetes | 36 | Jan 2008actual | — | 2014-04-02 |
| Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High CholesterolNCT00145574results2010-01-26Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8.Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: colesevelam HCl, placebo | Hypercholesterolemia | 194 | Dec 2007actual | — | 2010-04-15 |
| An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II DiabetesNCT00403481results2009-09-15Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.Non-randomized · Open-label · Treatment | Phase 4 | Completed | Drug: olmesartan medoxomil, Olmesartan medoxomil plus Hydrochlorothiazide | Hypertension | 192 | Nov 2007actual | — | 2016-11-03 |
| A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II HypertensionNCT00430638results2010-01-22Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary, Placebo | Hypertension | 278 | Oct 2007actual | — | 2018-10-02 |
| A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee ArthroplastyNCT01203072results2015-01-26Proportion of Subjects With Venous Thromboembolism Events.Randomized · Quadruple-masked · Prevention | Phase 2 | Completed | Drug: DU-176b, DU-176b, DU-176b, DU-176b, Placebo | Venous Thromboembolism, Deep Vein Thrombosis, Total Knee Arthroplasty | 523 | Sep 2007actual | — | 2019-02-25 |
| Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 DiabetesNCT00151762To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapyNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Colesevelam hydrochloride | Type 2 Diabetes | 780 | Jul 2007actual | — | 2008-01-09 |
| Evaluation of the Additional Efficacy, and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential HypertensionNCT00872586Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups.Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: olmesartan medoxomil + hydrochlorothiazide, olmesartan medoxomil | Essential Hypertension | 304 | Jul 2007actual | — | 2010-09-29 |
| A Study of DU-176b in Preventing Blood Clots After Hip Replacement SurgeryNCT00398216results2015-02-25Adjudicated Incidence of VTERandomized · Double-masked · Prevention | Phase 2 | Completed | Drug: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor | Thrombosis, Hip Replacement | 903 | Jun 2007actual | — | 2019-02-26 |
| Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential HypertensionNCT00890591results2009-04-30Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)Open-label · Treatment | Phase 4 | Completed | Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary | Essential Hypertension | 144 | Jun 2007actual | — | 2009-06-03 |
| The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip OsteoarthritisNCT00330135Change in overall pain, 3 months after a single intra-articular injection. The intensity of the pain will be evaluated using a continuous VAS of 100 mm of the overall level of pain in the affected hip.Randomized · Double-masked · Treatment | Phase 3 | Terminated | Drug: Sodium hyaluronate, placebo injection | Symptomatic Hip Osteoarthritis | 85 | Mar 2007actual | — | 2008-01-09 |
| Efficacy of SUN N4057 in Subjects With Acute Ischemic Stroke and Measurable Penumbra on Magnetic Resonance Imaging (MRI)NCT00272909Improvement in MRIRandomized · Quadruple-masked · Treatment | Phase 2 | Terminated | Drug: piclozotan low dose, placebo, piclozotan high dose | Stroke | 43 | Oct 2006actual | — | 2015-10-20 |
| Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes MellitusNCT00361153To evaluate the effect of 8 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method, i.e., placebo-corrected change from baseline in M-value.Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: Colesevelam hydrochloride, placebo | Type 2 Diabetes Mellitus | 35 | Oct 2006actual | — | 2008-06-25 |
| Treatment of High Blood Pressure Using Olmesartan With Hydrochlorothiazide Compared to an ACE Inhibitor With a Calcium Channel BlockerNCT00185120Change in systolic blood pressure from the start of the studyRandomized · Double-masked · Treatment | Phase 4 | Completed | Drug: Olmesartan medoxomil, Hydroclorothiazide, Benazepril, Amlodipine | Hypertension | 152 | Sep 2006actual | — | 2012-01-18 |
| DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal AdenocarcinomaNCT00080834Open-label · Treatment | Phase 2 | Completed | Drug: DJ-927 | Colorectal Cancer | — | Aug 2006actual | — | 2012-05-16 |
| WelChol® and Sulfonylurea in Treating Patients With Type 2 DiabetesNCT00147758To assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapyRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Colesevelam hydrochloride | Type 2 Diabetes | 400 | Aug 2006actual | — | 2012-01-18 |
| WelChol® With Metformin in Treating Patients With Type 2 DiabetesNCT00147719To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapyRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Colesevelam hydrochloride | Type 2 Diabetes | 300 | Jul 2006actual | — | 2012-01-18 |
| Exatecan Mesylate in Treating Children With Relapsed or Refractory RhabdomyosarcomaNCT00055939Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: exatecan mesylate | Sarcoma | — | Apr 2006actual | — | 2012-05-16 |
| Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell TumorNCT00055952Open-label · Treatment | Phase 2 | Completed | Drug: exatecan mesylate | Sarcoma | — | Apr 2006actual | — | 2012-05-16 |
| Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic NephropathyNCT00914524The change in the urinary protein/creatinine ratio from baseline to the end of treatment.Open-label · Treatment | Phase 2 | Completed | Drug: olmesartan medoxomil | Chronic Glomerulonephritis, Diabetic Nephropathy | 49 | Apr 2006actual | — | 2010-09-29 |
| Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Carotid Artery Disease. This Study is Also Known as CAPTIVATE.NCT00151788To demonstrate the effect of pactimibe versus placebo, when added to usual medical care, on the intima-media thickness (IMT) of the carotid arteries in subjects with heterozygous familial hypercholesterolemia (HeFH) and carotid atherosclerosis.Randomized · Double-masked · Treatment | Phase 2/3 | Terminated | Drug: Pactimibe sulfate | Atherosclerosis, Heterozygous Familial Hypercholesterolemia | 796 | Mar 2006actual | — | 2012-01-18 |
| Evaluation of the Effects of Carperitide in Patients With Congestive Heart FailureNCT00259038Change from baseline in pulmonary capillary wedge pressure (PCWP)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Carperitide, Placebo | Heart Failure, Congestive, Heart Decompensation, Left Ventricular Failure, Myocardiopathies, Systolic or Diastolic Left Ventricular Dysfunction | 162 | Feb 2006actual | — | 2016-11-08 |
| DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid TumorsNCT00077077Open-label · Treatment | Phase 1 | Completed | Drug: DJ-927, capecitabine | Unspecified Adult Solid Tumor, Protocol Specific | — | Jan 2006actual | — | 2012-05-16 |
| Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue SarcomaNCT00064220Open-label · Treatment | Phase 2 | Completed | Drug: soblidotin | Sarcoma | — | Dec 2005actual | — | 2012-05-16 |
| Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip ReplacementNCT00107900results2015-03-02Prevention of Venous Thromboembolism (VTE)Non-randomized · Open-label · Prevention | Phase 2 | Completed | Drug: DU-176b | Arthroplasty, Replacement, Hip, Thrombosis | 606 | Dec 2005actual | — | 2019-02-26 |
| Placebo and Active Controlled Study of Rivoglitazone in Type 2 DiabetesNCT00143520Change in HbA1cRandomized · Double-masked · Treatment | Phase 2/3 | Completed | Drug: Rivoglitazone, Pioglitazone, Placebo | Type 2 Diabetes | 441 | Dec 2005actual | — | 2021-05-10 |
| WelChol® and Insulin in Treating Patients With Type 2 DiabetesNCT00151749- To assess the additional lowering of HbA1c achieved byRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Colesevelam hydrochloride | Type 2 Diabetes | 260 | Dec 2005actual | — | 2012-01-18 |
| Vascular Improvement With Olmesartan Medoxomil StudyNCT00772499Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapyRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure, atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure | Hypertension | 100 | Jul 2005actual | — | 2008-10-15 |
| Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in HypertensionNCT00858702results2009-08-26The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85Randomized · Open-label · Treatment | Phase 4 | Completed | Drug: olmesartan medoxomil and a CCB, olmesartan medoxomil and a diuretic | Hypertension | 105 | Jul 2005actual | — | 2017-10-11 |
| Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung CancerNCT00061854Open-label · Treatment | Phase 2 | Completed | Drug: soblidotin | Lung Cancer | — | May 2005actual | — | 2012-05-16 |
| DX-8951f in Treating Patients With Metastatic Cancer of the PancreasNCT00003951Treatment | Phase 2 | Completed | Drug: exatecan mesylate | Pancreatic Cancer | 37 | Apr 2005actual | — | 2012-05-16 |
| Chemotherapy in Treating Patients Who Have Hematologic CancerNCT00004047Treatment | Phase 1 | Completed | Drug: exatecan mesylate | Leukemia, Myelodysplastic Syndromes | — | Apr 2005actual | — | 2012-05-16 |
| DX-8951f in Treating Patients With Liver CancerNCT00004108Treatment | Phase 2 | Completed | Drug: exatecan mesylate | Liver Cancer | — | Apr 2005actual | — | 2012-05-16 |
| DX-8951f in Treating Patients With Biliary CancerNCT00005938Treatment | Phase 2 | Completed | Drug: exatecan mesylate | Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer | — | Apr 2005actual | — | 2012-05-16 |
| Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic CancerNCT00023972Randomized · Open-label · Treatment | Phase 3 | Completed | Drug: exatecan mesylate, gemcitabine hydrochloride | Pancreatic Cancer | — | Apr 2005actual | — | 2012-05-16 |
| Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential HypertensionNCT00856271Change of trough seated diastolic blood pressure from baseline to 8 weeksRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: olmesartan medoxomil, losartan potassium | Essential Hypertension | 287 | Feb 2005actual | — | 2010-09-29 |
| DX-8951f in Treating Children With Advanced Solid Tumors or LymphomasNCT00004212Treatment | Phase 1 | Completed | Biological: filgrastim · Drug: exatecan mesylate | Brain and Central Nervous System Tumors, Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific | — | Apr 2004actual | — | 2012-05-16 |
| DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the CervixNCT00004866Treatment | Phase 2 | Completed | Drug: exatecan mesylate | Cervical Cancer | — | Sep 2003actual | — | 2012-05-16 |
| DX-8951f in Treating Patients With Metastatic Stomach CancerNCT00017212Treatment | Phase 2 | Completed | Drug: exatecan mesylate | Esophageal Cancer, Gastric Cancer | — | Sep 2003actual | — | 2012-05-16 |
| Study to Compare Welchol and TriCor to TriCor Alone in Patients With High CholesterolNCT00754039% change in LDL-C from baselineRandomized · Triple-masked · Treatment | Phase 4 | Completed | Drug: colesevelam HCl tablets and fenofibrate tablets, fenofibrate tablets and Welchol placebo tablets, fenofibrate tablets and Welchol placebo tablets | Hypercholesterolemia, Hyperlipidemia, Familial Combined | 129 | Sep 2003actual | — | 2015-04-03 |
| Olmesartan Medoxomil Versus Losartan in Patients With HypertensionNCT00857285results2009-07-23Mean Change of Sitting dBP From Baseline to Week 12Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: olmesartan medoxomil, losartan potassium | Essential Hypertension | 130 | Aug 2003actual | — | 2009-07-23 |
| A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.NCT00753779The percent change in LDL-C from baseline to endpointRandomized · Double-masked · Treatment | Phase 4 | Completed | Drug: colesevelam HCl tablets, and simvastatin tablets, simvastatin tablets and colesevelam HCl placebo | Hypercholesterolemia | 72 | Jun 2003actual | — | 2015-04-03 |
| A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Atorvastatin for at Least 4 Weeks.NCT00754507The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint.Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: colesevelam HCl tablets, and atorvastatin tablets, colesevelam HCl placebo tablets and atorvastatin tablets | Hypercholesterolemia | 65 | Jun 2003actual | — | 2015-04-03 |
| A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Pravastatin for at Least 4 Weeks.NCT00755352The primary efficacy parameter was the percent change in LDL-C from baseline to endpoint.Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: pravastatin tablets and Welchol tablets, pravastatin tablets and Welchol placebo tablets | Hypercholesterolemia | 67 | Jun 2003actual | — | 2015-04-03 |
| Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in ChildrenNCT00781521Sponsor determined clinical cure of otitis mediaNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: ofloxacin otic solution 0.3% | Otitis Media | 96 | Apr 2003actual | — | 2008-10-29 |
| Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck CancerNCT00017511Supportive care | Phase 3 | Completed | Drug: cevimeline hydrochloride | Head and Neck Cancer, Oral Complications, Radiation Toxicity | — | Mar 2003actual | — | 2012-05-16 |
| Chemotherapy in Treating Women With Metastatic Breast CancerNCT00004046Treatment | Phase 2 | Completed | Drug: exatecan mesylate | Breast Cancer | — | Apr 2002actual | — | 2012-05-16 |
| Chemotherapy in Treating Patients With Prostate CancerNCT00004045Treatment | Phase 2 | Completed | Drug: exatecan mesylate | Prostate Cancer | — | Aug 2001actual | — | 2012-05-16 |
| Chemotherapy in Treating Patients With Recurrent, Metastatic, or Unresectable Ovarian, Fallopian Tube, or Peritoneal CancerNCT00004060Treatment | Phase 2 | Completed | Drug: exatecan mesylate | Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer | — | Sep 2000actual | — | 2012-05-16 |
| Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Coronary Artery DiseaseNCT00185042To compare the effect of CS-505 versus placebo when added to usual medical care on the change from baseline in percent atheroma volume, as measured by intravascular ultrasound (IVUS) of the identified target coronary artery segmentRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: Pactimibe, CS-505 | Coronary Heart Disease | 534 | — | — | 2007-09-11 |
| The Relative Effects of Olmesartan Medoxomil, Irbesartan and Valsartan on the Activity of the Blood Pressure Control System in Healthy SubjectsNCT00185055To characterize the plasma renin activity (PRA) and urinary aldosterone response patterns to single doses of olmesartan medoxomil, irbesartan, and valsartan compared to placebo in normal volunteers.Randomized · Single-masked · Treatment | Phase 4 | Completed | Drug: Olmesartan medoxomil, Irbesartan, Valsartan | Healthy | 20 | — | — | 2005-09-16 |
| An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With HypertensionNCT00185068Change in mean trough seated systolic blood pressure compared to the start of the studyNon-randomized · Open-label · Treatment | Phase 4 | Completed | Drug: Olmesartan medoxomil, Olmesartan medoxomil/hydrochlorothiazide, Hydrochlorothiazide | Hypertension | 110 | — | — | 2005-09-16 |
| A Comparison of the Effect of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on the Ability of Overweight Patients With High Blood Pressure to Respond to InsulinNCT00185094To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivityRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: Olmesartan medoxomil, Losartan potassium, Atenolol | Hypertension, Insulin Resistance, Metabolic Syndrome | 60 | — | — | 2005-12-23 |
| Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High CholesterolNCT00185107The percent change in LDL-C from the start of the studyRandomized · Double-masked · Treatment | Phase 4 | Completed | Drug: Colesevelam Hydrochloride, Ezetimibe, Simvastatin | Hypercholesterolemia | 45 | — | — | 2007-09-11 |
| Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe HypertensionNCT00185133Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment armRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Olmesartan medoxomil, Amlodipine | Hypertension | 1,900 | — | — | 2018-12-24 |
| Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917NCT00290940Mean change from baseline in HbA1C after 12 weeks compared to placeboRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: CS-917, metformin hydrochloride, pioglitazone | Diabetes Mellitus, Type 2 | 400 | — | — | 2007-09-11 |
| Study of CS-1008 in Patients With Advanced Solid Malignancies and Lymphomas (Without Leukemic Component)NCT00320827To determine the recommended Phase 2 doseNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CS-1008 (humanized anti-DR5 antibody) | Malignancies, Lymphoma | 40 | — | — | 2007-09-11 |
| A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established AtherosclerosisNCT00382213The primary endpoint for the determination of efficacy will be a composite ofRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Olmesartan medoxomil, Placebo | Atherosclerosis | 210 | — | — | 2023-06-01 |
| Expanded Treatment Protocol for Adults With FLT3-ITD Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) to Receive QuizartinibNCT03746912expanded access | — | No longer available | Drug: Quizartinib Dihydrochloride | Acute Myeloid Leukemia With Gene Mutations | — | — | — | 2020-04-15 |
| Medical Access Program for Patritumab DeruxtecanNCT06099639expanded access | — | No longer available | Drug: HER3-DXd | Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer | — | — | — | 2025-06-08 |
| Medical Access Program for Datopotamab Deruxtecan in EGFRm NSCLC PatientsNCT06279728expanded access | — | Approved for marketing | Drug: Datopotamab deruxtecan | EGFRm Advanced Non-Small Cell Lung Cancer, EGFRm Metastatic Non-Small Cell Lung Cancer | — | — | — | 2025-07-03 |
| Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung CancerNCT07535359expanded access | — | Available | Drug: Ifinatamab Deruxtecan | SCLC, Extensive-stage Small Cell Lung Cancer | — | — | — | 2026-08-07 |
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