Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)
Public ClinicalTrials.gov record NCT04811092. 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 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04811092
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Industry
- Enrollment
- 321 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
- Mar 18, 2022 (Actual)
- Primary completion
- Apr 3, 2025 (Actual)
- Completion
- Apr 3, 2025 (Actual)
- Last update posted
- Jun 8, 2026
2022 – 2025
United States locations
- U.S. sites
- 28
- U.S. states
- 19
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Pulmonary Specialists ( Site 1010) | Scottsdale | Arizona | 85258 | — |
| University of Arizona ( Site 1006) | Tucson | Arizona | 85724 | — |
| University of California San Diego ( Site 1002) | La Jolla | California | 92037 | — |
| UCLA Medical Center ( Site 1068) | Los Angeles | California | 90095 | — |
| University of California Irvine ( Site 1086) | Orange | California | 92868 | — |
| Santa Barbara Pulmonary Associates ( Site 1060) | Santa Barbara | California | 93105-5316 | — |
| University of California Davis Medical Center ( Site 1064) | Sherman Oaks | California | 95817 | — |
| University of Colorado Hospital ( Site 1013) | Aurora | Colorado | 80045 | — |
| AdventHealth Medical Group Advanced Lung Disease ( Site 1058) | Orlando | Florida | 32804 | — |
| University of Iowa Hospital and Clinics ( Site 1050) | Iowa City | Iowa | 52242 | — |
| Johns Hopkins Hospital ( Site 1036) | Baltimore | Maryland | 21287-0005 | — |
| Tufts Medical Center - PPDS ( Site 1014) | Boston | Massachusetts | 02111-1526 | — |
| Boston Medical Center ( Site 1012) | Boston | Massachusetts | 02118 | — |
| University of Michigan ( Site 1011) | Ann Arbor | Michigan | 48109 | — |
| University of Kansas Medical Center ( Site 1020) | Kansas City | Missouri | 66160 | — |
| Washington University School of Medicine ( Site 1022) | St Louis | Missouri | 63110 | — |
| University of New Mexico, Health Sciences Center ( Site 1048) | Albuquerque | New Mexico | 87131 | — |
| NYU Langone Health ( Site 1052) | New York | New York | 10016-9196 | — |
| University of North Carolina at Chapel Hill ( Site 1042) | Chapel Hill | North Carolina | 27514 | — |
| The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) | Cincinnati | Ohio | 45219 | — |
| University of Cincinnati ( Site 1035) | Cincinnati | Ohio | 45219 | — |
| The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065) | Cleveland | Ohio | 44195 | — |
| Nazih Zuhdi Transplantation Institute ( Site 1084) | Oklahoma City | Oklahoma | 73112-4421 | — |
| Oregon Health & Science University ( Site 1054) | Portland | Oregon | 97239 | — |
| Medical University of South Carolina ( Site 1003) | Charleston | South Carolina | 29425-8900 | — |
| Vanderbilt University Medical Center ( Site 1027) | Nashville | Tennessee | 37232 | — |
| University of Texas Southwestern Medical Center ( Site 1038) | Dallas | Texas | 78701 | — |
| University of Utah ( Site 1049) | Salt Lake City | Utah | 84132-0001 | — |
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 124 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04811092, 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 Jun 8, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04811092 live on ClinicalTrials.gov.