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.

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.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Dec 2017

At a glance

  • Drugs Macitentan (Primary)
  • Indications Heart disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms RUBATO
  • Sponsors Actelion Pharmaceuticals
  • Most Recent Events

    • 09 Nov 2017 Planned End Date changed from 9 Mar 2020 to 28 Mar 2020.
    • 09 Nov 2017 Planned primary completion date changed from 9 Jun 2019 to 28 Mar 2020.
    • 29 Sep 2017 Planned initiation date changed from 20 Sep 2017 to 20 Oct 2017.
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