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A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020) - Trial NCT05818137

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.

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NCT05818137
Phase 3
Recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT05818137
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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)

Study Focus

Sotatercept

Interventional

biological

Sponsor & Location

Merck Sharp & Dohme LLC

Narashino,Kure,Okayama, Japan

Timeline & Enrollment

Phase 3

May 10, 2023

Jul 24, 2026

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 hypertension
Other secondary pulmonary hypertension
Pulmonary heart disease and diseases of pulmonary circulation
Stenosis of pulmonary artery
Pulmonary heart disease, unspecified

Data Source

ClinicalTrials.gov

NCT05818137

Non-Device Trial