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NCT04811092 · ClinicalTrials.gov registry record · Phase 3
Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)
A Phase 3 study, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.
- Terminated
- Registry status
- Phase 3
- Development phase
- 321
- Enrollment target
NCT04811092: Clinical Trial Phase 3 study, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.
NCT04811092 is a Phase 3 study that was terminated before completion, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA. The registered enrollment target is 321 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
NCT04811092, a Phase 3 study, was terminated before completion, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 321 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension \[PAH\] therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high-risk of disease progression.
Primary Outcome
Time to clinical worsening (TTCW) is defined as time from randomization to the first confirmed morbidity event or death. Clinical worsening events are defined as all-cause death, non-planned PAH-related hospitalization of ≥ 24 hours in duration, atrial septostomy, lung transplant, and/or deterioration in performance in 6-minute walk test from baseline combined with one of the following conditions: worsening of WHO FC from baseline, signs/symptoms of increased right heart failure, addition of a b
Interventions
- OTHER Placebo
- DRUG Sotatercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2022-03-18 |
| Est. Completion | 2025-04-03 |
| Phase | Phase 3 |
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA14 total trials
Why NCT04811092 stopped before completion
NCT04811092 is an interventional study that assigns participants to a tested intervention. The registered 321 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 2 interventions - of which Placebo is the first listed.
NCT04811092 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04811092 about?
NCT04811092 is a clinical study titled "Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)". The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension \[PAH\] therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnos...
What is the current status of trial NCT04811092?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 321 participants. The study started on 2022-03-18. Estimated completion is 2025-04-03.
What interventions are being tested in trial NCT04811092?
The interventions under investigation include: Placebo (OTHER), Sotatercept (DRUG).
Who is sponsoring clinical trial NCT04811092?
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 NCT04811092's enrollment target sits among peer trials
321 1081st of 2000 higher than 919 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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