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NCT03626688 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
A Phase 3 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 687
- Enrollment target
NCT03626688: Completed Phase 3 study, sponsored by United Therapeutics.
NCT03626688 is a Phase 3 study that has completed, run by United Therapeutics. The registered enrollment target is 687 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03626688, a Phase 3 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 687 participants
- Enrollment target
Study Summary
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
Primary Outcome
Clinical worsening events are defined as death, nonelective hospital admission for worsening PAH (further defined in clinical study protocol), initiation of parenteral or inhaled prostacyclin pathway agent for treatment of worsening PAH, disease progression (further defined in clinical study protocol), or unsatisfactory long-term clinical response (further defined in clinical study protocol).
Interventions
- DRUG Placebo
- DRUG Ralinepag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 687 participants |
| Start Date | 2019-01-24 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
What the finished NCT03626688 record still lists
NCT03626688 is an interventional study that assigns participants to a tested intervention. The registered 687 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03626688 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03626688 about?
NCT03626688 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients". Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
What is the current status of trial NCT03626688?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 687 participants. The study started on 2019-01-24. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT03626688?
The interventions under investigation include: Placebo (DRUG), Ralinepag (DRUG).
Who is sponsoring clinical trial NCT03626688?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03626688's enrollment target sits among peer trials
687 525th of 2000 higher than 1,476 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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