A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
687actual
Sites
209
Countries
Argentina, Australia, Austria +30
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-01-24 | actual | When the study began enrolling |
| Primary completion | 2025-12-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-31 | actual | The whole study's end, after follow-up |
| First posted | 2018-08-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- PAH
- Pulmonary Hypertension
- Pulmonary Arterial Hypertension
- Hypertension
- Connective Tissue Diseases
- Familial Primary Pulmonary Hypertension
- Vascular Diseases
- Cardiovascular Diseases
- Hypertension, Pulmonary
- Lung Diseases
- Respiratory Tract Disease
Interventions
- Drug: Ralinepag — also filed as APD811
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFTime from randomization to the first adjudicated protocol-defined clinical worsening event
measured The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study, up to 3 years
Publications
- PMID 42520828 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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