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Completed Phase 3 Interventional Results available

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)

ClinicalTrials.gov ID: NCT04576988

Public ClinicalTrials.gov record NCT04576988. 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.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 1:50 AM EDT

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 Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04576988
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
324 participants

Conditions and interventions

Interventions

Biological · Drug

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
Jan 25, 2021 (Actual)
Primary completion
Aug 26, 2022 (Actual)
Completion
Dec 6, 2022 (Actual)
Last update posted
Sep 19, 2024

2021 – 2022

United States locations

U.S. sites
39
U.S. states
24
U.S. cities
35
Facility City State ZIP Site status
Arizona Pulmonary Specialists (Site 1010) Phoenix Arizona 85012 —
Pulmonary Associates, PA (Site 1008) Phoenix Arizona 85032 —
University of Arizona (Site 1006) Tucson Arizona 85724 —
University of California San Diego Medical Center (Site 1002) San Diego California 92037 —
University of California - Davis Medical Center (Site 1064) Sherman Oaks California 95817 —
Stanford University Medical Center (Site 1024) Stanford California 94305 —
Harbor UCLA Medical Center (Site 1028) Torrance California 90502 —
University of Colorado Hospital (Site 1013) Aurora Colorado 80045 —
The George Washington University Medical Faculty Associates (Site 1025) Washington D.C. District of Columbia 20037 —
Mayo Clinic Jacksonville (Site 1045) Jacksonville Florida 32256 —
University of South Florida (Site 1043) Tampa Florida 33606 —
The Emory Clinic (Site 1030) Atlanta Georgia 30322 —
Norton Pulmonary Specialists (Site 1066) Louisville Kentucky 40202 —
Tufts Medical Center - PPDS (Site 1012) Boston Massachusetts 02111 —
Brigham and Women's Hospital (Site 1014) Boston Massachusetts 02115 —
University of Michigan (Site 1011) Ann Arbor Michigan 48109-5936 —
University of Minnesota (Site 1062) Minneapolis Minnesota 55455 —
Mayo Clinic (Site 1023) Rochester Minnesota 55905 —
University of Kansas Medical Center (Site 1020) Kansas City Missouri 66160-7232 —
Washington University School of Medicine (Site 1022) St Louis Missouri 63110 —
Nebraska Medical Center (Site 1053) Omaha Nebraska 68105 —
Renown Institute for Heart & Vascular Health (Site 1055) Reno Nevada 89502-1262 —
New York Presbyterian Hospital (Site 1046) New York New York 10032 —
Duke University Medical Center (Site 1026) Durham North Carolina 27710 —
University of Cincinnati Medical Center (Site 1035) Cincinnati Ohio 45219-2316 —
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital (Site 1001) Cincinnati Ohio 45219 —
University Hospitals Cleveland Medical Center (Site 1005) Cleveland Ohio 44106 —
The Ohio State University Wexner Medical Center (Site 1032) Columbus Ohio 43210 —
Oregon Health and Science University (Site 1054) Portland Oregon 97232 —
University of Pennsylvania (Site 1047) Philadelphia Pennsylvania 19104 —
UPMC Presbyterian. UPMC Presbyterian Hospital (Site 1059) Pittsburgh Pennsylvania 15213 —
Rhode Island Hospital (Site 1033) Providence Rhode Island 02903 —
Medical University of South Carolina - PPDS (Site 1003) Charleston South Carolina 29425-8900 —
Statcare Pulmonary Consultants - Knoxville (Site 1031) Knoxville Tennessee 37919 —
Vanderbilt University Medical Center (Site 1027) Nashville Tennessee 37232 —
CHI St. Luke's Health Baylor College of Medicine Medical Center (Site 1044) Houston Texas 77030 —
Houston Methodist Hospital (Site 1009) Houston Texas 77030 —
University of Utah - PPDS (Site 1049) Salt Lake City Utah 84132 —
University of Washington Medical Center - Montlake (Site 1067) Seattle Washington 98195-0001 —

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 81 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04576988, 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 Sep 19, 2024 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04576988 live on ClinicalTrials.gov.

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