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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

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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 Nov 2019

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At a glance

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

    • 12 Nov 2019 According to an Actelion Pharmaceuticals media release, the company has announced to voluntarily withdraw the European and other health authority filings still under review to extend the indication of OPSUMIT(macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). This decision was not driven by any safety concerns. Actelion intends to generate additional data to support future CTEPH filings in Europe, U.S. and worldwide.
    • 22 May 2019 Results comparing the efficacy and safety of macitentan vs riociguat using matching-adjusted indirect comparison between patiatnt populatrion of CHEST-1 and MERIT-1 respectively presented at the 24th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
    • 16 Jan 2019 According to an Actelion Pharmaceuticals media release, the company has received a complete response letter from the U.S. FDA for its supplemental New Drug Application (sNDA) for OPSUMIT (macitentan) in the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) to improve pulmonary vascular resistance and exercise capacity. The complete response letter indicates additional data are needed to evaluate the use of of OPSUMIT in the treatment of CTEPH.
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