A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
Recruiting now · Phase 3
Conditions studied: Pulmonary Arterial Hypertension
In brief
Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse. Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH. This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.
Key facts
- Study ID
- NCT07218029
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 815
- Starts
- 2021-05-12
- Expected to finish
- 2028-12-07
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The main inclusion criteria include but are not limited to the following:
- Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
- Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
- Must have the ability to understand and provide documented informed consent
You may not qualify if…
- The main exclusion criteria include but are not limited to the following:
- Did not participate in a sotatercept PAH parent study
- Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
- Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
- Is a female who is pregnant or breastfeeding
- Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
- Is currently enrolled in another investigational product study other than a sotatercept study
- Is incapacitated
Where it is running
- Instituto do Coracao - HCFMUSP ( Site 1803) — São Paulo, Brazil (enrolling)
- Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311) — Nice, Alpes-Maritimes, France (enrolling)
- Froedtert Hospital & the Medical College of Wisconsin ( Site 1051) — Milwaukee, Wisconsin, United States (enrolling)
- Hospital Dia do Pulmao ( Site 1802) — Blumenau, Santa Catarina, Brazil (enrolling)
- University of Alberta Hospital ( Site 2101) — Edmonton, Alberta, Canada (enrolling)
- University of Arizona ( Site 1006) — Tucson, Arizona, United States (enrolling)
- Medical University of South Carolina ( Site 1003) — Charleston, South Carolina, United States (enrolling)
- Houston Methodist Hospital ( Site 1009) — Houston, Texas, United States (enrolling)
- Royal Adelaide Hospital ( Site 1109) — Adelaide, South Australia, Australia (enrolling)
- Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805) — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
- UC Davis - Medial Center ( Site 1064) — Sacramento, California, United States (enrolling)
- Peter Lougheed Centre ( Site 2102) — Calgary, Alberta, Canada (enrolling)
- Tampa General Hospital ( Site 1043) — Tampa, Florida, United States (enrolling)
- University of Kansas Medical Center ( Site 1020) — Kansas City, Kansas, United States (enrolling)
- Norton Pulmonary Specialists ( Site 1066) — Louisville, Kentucky, United States (enrolling)
- Arizona Pulmonary Specialists ( Site 1010) — Scottsdale, Arizona, United States (enrolling)
- Tufts Medical Center ( Site 1012) — Boston, Massachusetts, United States (enrolling)
- Brigham and Women's Hospital ( Site 1014) — Boston, Massachusetts, United States (enrolling)
- Royal Prince Alfred Hospital ( Site 1106) — Camperdown, New South Wales, Australia (enrolling)
- The Prince Charles Hospital ( Site 1104) — Chermside, New South Wales, Australia (enrolling)
- George Washington University Medical Faculty Associates ( Site 1025) — Washington D.C., District of Columbia, United States (enrolling)
- Royal Hobart Hospital ( Site 1107) — Hobart, Tasmania, Australia (enrolling)
- The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) — Cincinnati, Ohio, United States (enrolling)
- University of Cincinnati Medical Center ( Site 1035) — Cincinnati, Ohio, United States (enrolling)
- CHU Bordeaux Haut-Leveque ( Site 1312) — Pessac, Aquitaine, France (enrolling)
Full record on ClinicalTrials.gov
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