A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)
Public ClinicalTrials.gov record NCT03496207. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03496207
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Industry
- Enrollment
- 106 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 12, 2018
- Primary completion
- Mar 8, 2022
- Completion
- Mar 8, 2022
- Last update posted
- Apr 18, 2023
2018 – 2022
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pulmonary Associates, PA | Phoenix | Arizona | 85006 | — |
| Arizona Pulmonary Specialists | Phoenix | Arizona | 85012 | — |
| Banner-University Medical Center Phoenix | Phoenix | Arizona | 85381 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| University of California, San Francisco Medical Center | San Francisco | California | 94143 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| UF Health Shands Hospital | Gainesville | Florida | 32610 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Lindner Clinical Trial Center | Cincinnati | Ohio | 45129 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03496207, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 18, 2023 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03496207 live on ClinicalTrials.gov.