Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

Trial Profile

Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

Completed
Phase of Trial: Phase II

Latest Information Update: 30 Jul 2018

At a glance

  • Drugs Macitentan (Primary)
  • Indications Pulmonary hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms MERIT-1
  • Sponsors Actelion Pharmaceuticals
  • Most Recent Events

    • 30 Apr 2018 According to an Actelion Pharmaceuticals media release, the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of OPSUMIT (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) to improve exercise capacity and pulmonary vascular resistance (PVR). The application was based on data from MERIT-1 trial.
    • 24 May 2017 Results presented at the 113th International Conference of the American Thoracic Society
    • 07 Nov 2016 Primary endpoint has been met. (Pulmonary vascular resistance (PVR) at rest at Week 16 expressed as percent of baseline PVR at rest), as per Actelion Ltd media release.
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