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NCT03496207 · ClinicalTrials.gov registry record · Phase 2
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)
A Phase 2 study, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.
- Completed
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
NCT03496207: Completed Phase 2 study, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.
NCT03496207 is a Phase 2 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 106 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03496207, a Phase 2 study, has completed, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
Study Summary
Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011) relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible participants will receive study treatment for 24 weeks during the placebo-controlled treatment period, and then will be eligible to enroll into a 30-month extension period during which all participants will receive sotatercept. All treated patients will also undergo a follow-up period after last study drug treatment.
Primary Outcome
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and at 24 weeks.
Interventions
- DRUG Placebo
- OTHER SOC
- DRUG Sotatercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2018-06-13 |
| Est. Completion | 2022-03-09 |
| Phase | Phase 2 |
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA14 total trials
What the finished NCT03496207 record still lists
NCT03496207 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03496207 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03496207 about?
NCT03496207 is a clinical study titled "A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)". Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011) relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible participants will receive study treatment for 24 weeks during the placebo-controlled treatment period, and then will be eligible t...
What is the current status of trial NCT03496207?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2018-06-13. Estimated completion is 2022-03-09.
What interventions are being tested in trial NCT03496207?
The interventions under investigation include: Placebo (DRUG), SOC (OTHER), Sotatercept (DRUG).
Who is sponsoring clinical trial NCT03496207?
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 NCT03496207's enrollment target sits among peer trials
106 648th of 2000 higher than 1,351 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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