CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 324 enrolled
Drug / intervention
Sotatercept +2 morebiological
Likely dose
Sotatercept 0.3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04576988
NCT04576988Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA·interventional·Posted Oct 6, 2020·Updated Sep 19, 2024

In Brief

A Phase 3 clinical trial evaluating Sotatercept, Placebo, and 1 other intervention for Pulmonary Arterial Hypertension. Completed, enrolled 324 participants across 120 sites in 21 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesArgentina, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Serbia, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedOct 6, 2020
Enrollment StartJan 25, 2021
Primary CompletionAug 26, 2022
Study CompletionDec 6, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.7 years ago

Interventions

Sotaterceptbiological

Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy.

Placebodrug

Placebo administered subcutaneously (SC) every 21 days plus background PAH therapy.

Background PAH Therapydrug

Background PAH therapy may consist of the following drug classes: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist.