A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)
Completed · Phase 3 · Has a placebo group
Conditions studied: Pulmonary Arterial Hypertension
In brief
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.
Key facts
- Study ID
- NCT04576988
- Run by
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- People needed
- 324
- Starts
- 2021-01-25
- Expected to finish
- 2022-12-06
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Pulmonary Associates, PA (Site 1008) — Phoenix, Arizona, United States
- University of Arizona (Site 1006) — Tucson, Arizona, United States
- University of California San Diego Medical Center (Site 1002) — San Diego, California, United States
- University of California - Davis Medical Center (Site 1064) — Sherman Oaks, California, United States
- Stanford University Medical Center (Site 1024) — Stanford, California, United States
- Harbor UCLA Medical Center (Site 1028) — Torrance, California, United States
- University of Colorado Hospital (Site 1013) — Aurora, Colorado, United States
- The George Washington University Medical Faculty Associates (Site 1025) — Washington D.C., District of Columbia, United States
- Mayo Clinic Jacksonville (Site 1045) — Jacksonville, Florida, United States
- University of South Florida (Site 1043) — Tampa, Florida, United States
- The Emory Clinic (Site 1030) — Atlanta, Georgia, United States
- Norton Pulmonary Specialists (Site 1066) — Louisville, Kentucky, United States
- Tufts Medical Center - PPDS (Site 1012) — Boston, Massachusetts, United States
- Brigham and Women's Hospital (Site 1014) — Boston, Massachusetts, United States
- University of Michigan (Site 1011) — Ann Arbor, Michigan, United States
- University of Minnesota (Site 1062) — Minneapolis, Minnesota, United States
- Mayo Clinic (Site 1023) — Rochester, Minnesota, United States
- University of Kansas Medical Center (Site 1020) — Kansas City, Missouri, United States
- Washington University School of Medicine (Site 1022) — St Louis, Missouri, United States
- Nebraska Medical Center (Site 1053) — Omaha, Nebraska, United States
- Renown Institute for Heart & Vascular Health (Site 1055) — Reno, Nevada, United States
- New York Presbyterian Hospital (Site 1046) — New York, New York, United States
- Duke University Medical Center (Site 1026) — Durham, North Carolina, United States
- University of Cincinnati Medical Center (Site 1035) — Cincinnati, Ohio, United States
- Arizona Pulmonary Specialists (Site 1010) — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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