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A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

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Trial Profile

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2023

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At a glance

  • Drugs Macitentan (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms SERAPHIN
  • Sponsors Actelion Pharmaceuticals
  • Most Recent Events

    • 24 May 2023 Results of meta analysis (n=1982 from 3 studies NCT01106014 , NCT00660179 and NCT00303459) assessing Outcomes in Patients With Pulmonary Arterial Hypertension (PAH) Associated With Congenital Heart Disease (CHD) Receiving PAH Medication presented at the 119th International Conference of the American Thoracic Society
    • 01 Aug 2022 Results assessing adjusting overall survival estimates of macitentan in pulmonary arterial hypertension after treatment switching, published in the Advances in Therapy.
    • 12 Jul 2022 Results published in the Advances in Therapy

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