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Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects

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Trial Profile

Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Sep 2022

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At a glance

  • Drugs Macitentan (Primary)
  • Indications Congenital heart defects
  • Focus Registrational; Therapeutic Use
  • Acronyms RUBATO
  • Sponsors Actelion Pharmaceuticals

    • Most Recent Events

    • 29 Aug 2022 Primary endpoint (Change in peak VO2 (oxygen uptake)) has not been met, as per results presented at the ESC Congress 2022 - Annual Congress of the European Society of Cardiology.
    • 29 Aug 2022 Results (n=137) assessing the efficacy and safety of macitentan in Fontan-palliated patients over 52 weeks, presented at the ESC Congress 2022 - Annual Congress of the European Society of Cardiology.
    • 05 Aug 2021 Status changed from active, no longer recruiting to completed.

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