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NCT04576988 · ClinicalTrials.gov registry record · Phase 3
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)
A Phase 3 study, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.
- Completed
- Registry status
- Phase 3
- Development phase
- 324
- Enrollment target
NCT04576988: Completed Phase 3 study, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.
NCT04576988 is a Phase 3 study that has completed, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA. The registered enrollment target is 324 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04576988, a Phase 3 study, has completed, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 324 participants
- Enrollment target
Study Summary
The objectives of this study are to evaluate the efficacy and safety of sotatercept (MK-7962) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The primary hypothesis of the study is that the participants receiving sotatercept will have improved 6-minute walk distance (6MWD) at 24 weeks compared to participants receiving placebo.
Primary Outcome
The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT). Per protocol, change from baseline in 6MWD at Week 24 was reported for DBPC period.
Interventions
- DRUG Placebo
- BIOLOGICAL Sotatercept
- DRUG Background PAH Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2022-12-06 |
| Phase | Phase 3 |
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA14 total trials
What the finished NCT04576988 record still lists
NCT04576988 is an interventional study that assigns participants to a tested intervention. The registered 324 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 (58% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04576988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04576988 about?
NCT04576988 is a clinical study titled "A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)". The objectives of this study are to evaluate the efficacy and safety of sotatercept (MK-7962) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The primary hypothesis of the study is that the partici...
What is the current status of trial NCT04576988?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 324 participants. The study started on 2021-01-25. Estimated completion is 2022-12-06.
What interventions are being tested in trial NCT04576988?
The interventions under investigation include: Placebo (DRUG), Sotatercept (BIOLOGICAL), Background PAH Therapy (DRUG).
Who is sponsoring clinical trial NCT04576988?
This trial is sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04576988's enrollment target sits among peer trials
324 1079th of 2000 higher than 920 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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