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A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg

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Trial Profile

A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg

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

Latest Information Update: 30 Apr 2025

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At a glance

  • Drugs Macitentan (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms UNISUS
  • Sponsors Actelion Pharmaceuticals

Most Recent Events

  • 14 Aug 2024 Status changed from recruiting to active, no longer recruiting.
  • 22 May 2024 Based on safety data (n=60, Sep 2021), the IDMC recommended to expand the study population to also include patients >75 years, after further evaluations at (n=310,Sep 2022) and (n=428, Mar 2023), the IDMC recommended to lift the close safety monitoring visits conducted in the 1st and 2nd weeks after each up-titration., according to trial design presented at the 120th International Conference of the American Thoracic Soci
  • 22 May 2024 Trial design presented at the 120th International Conference of the American Thoracic Society

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