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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Sep 2024

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At a glance

  • Drugs Sotatercept (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms STELLAR
  • Sponsors Acceleron Pharma

    • Most Recent Events

    • 13 Sep 2024 This trial has been Completed in Italy, According to European Clinical Trials Database record.
    • 26 Aug 2024 According to Merck & Co media release, based on results form this trial the European Commission (EC) has approved WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, to improve exercise capacity.
    • 28 Jun 2024 According to Merck & Co media release, based on this trial the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of WINREVAI (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, to improve exercise capacity.

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