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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk Mortality

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk Mortality

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 30 May 2024

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At a glance

  • Drugs Sotatercept (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms ZENITH
  • Sponsors Acceleron Pharma
  • Most Recent Events

    • 21 Mar 2024 Status changed from recruiting to active, no longer recruiting.
    • 27 Dec 2023 Planned End Date changed from 31 Dec 2026 to 28 Nov 2025.
    • 27 Dec 2023 Planned primary completion date changed from 30 Nov 2025 to 5 Sep 2025.
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