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NCT05818137Recruiting

A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)

A Phase 3 Non-randomized, Non-controlled, Open Label Clinical Study to Evaluate the Efficacy and Safety of MK-7962 (Sotatercept) add-on to Background Therapy in Japanese Participants With Pulmonary Arterial Hypertension (PAH)
Merck Sharp & Dohme LLCPhase 3ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Pulmonary Arterial Hypertension
Drug/Device/Intervention
Sotatercept
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Merck Sharp & Dohme LLC
Location
Narashino,Kure,Okayama, Japan
Timeline & enrollment
Phase
Phase 3
Start date
May 10, 2023
End date
Jul 24, 2026
Enrollment
35 participants
Primary outcome

Change from Pulmonary Vascular Resistance (PVR) from Baseline at Week 24,Number of Participants experiencing Adverse Events (AEs),Number of Participants who Discontinue Study Intervention due to AEs

Summary

This local Phase 3 study is planned to confirm the efficacy and safety in Japanese PAH
 participants. The primary population of this study is Japanese PAH participants with World
 Health Organization Functional Class (WHO FC) II or III while the study includes PAH
 participants with WHO FC I or IV as other populations. There are no hypotheses for this
 study.

ICD-10 classifications
Primary pulmonary hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationStenosis of pulmonary arteryPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05818137
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05818137 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme LLC and is currently Recruiting. The study focuses on Pulmonary Arterial Hypertension. Target enrollment is 35 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.