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NCT07899905
A Clinical Study of MK-7962 in Chinese Participants With Pulmonary Arterial Hypertension (MK-7962-022)
Conditions: Hypertension, Pulmonary
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 40
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for ways to treat people with a type of high blood pressure in the lungs called pulmonary arterial hypertension (PAH). This study focuses on Chinese participants who are already taking stable, standard-of-care medications for their PAH. Researchers want to know if adding the study treatment, sotatercept, to their current background treatment can help treat people with PAH.
Participants in this study will start a new treatment regimen where they will receive sotatercept as an add-on therapy, and researchers will monitor their health.
The main goals of this study are to learn if sotatercept is safe, if participants tolerate it well, and how effective it is at improving their exercise capacity and physical health when added to their ongoing PAH treatment.
Eligibility Criteria
Inclusion Criteria:
* Participants must have a documented diagnosis of Pulmonary Arterial Hypertension (PAH, WHO Group 1), classified as WHO Functional Class (FC) II or III.
* Must be on stable doses of background PAH therapy for at least 90 days prior to screening.
* Screening evaluation must show a 6-Minute Walk Distance (6MWD) between 150 and 500 meters.
* Hemodynamic assessment via Right Heart Catheterization (RHC) must confirm a Pulmonary Vascular Resistance (PVR) of ≥5 Wood units.
Exclusion Criteria:
* Participants with Pulmonary Hypertension from WHO Groups 2, 3, 4, or 5 are excluded.
* Excludes specific PAH subtypes, including those associated with: portal hypertension, Schistosomiasis-associated PAH, pulmonary veno-occlusive disease, and HIV.
* Participants with significant left-sided heart disease (e.g., LVEF \
Source: ClinicalTrials.gov (NCT07899905). StuddyBuddy aggregates publicly available trial information.