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.
Phase of Trial: Phase III
Latest Information Update: 04 Oct 2017
At a glance
- Drugs Macitentan (Primary)
- Indications Heart disorders
- Focus Registrational; Therapeutic Use
- Acronyms RUBATO
- Sponsors Actelion Pharmaceuticals
- 29 Sep 2017 Planned initiation date changed from 20 Sep 2017 to 20 Oct 2017.
- 29 Sep 2017 Status changed from not yet recruiting to recruiting.
- 06 Sep 2017 Planned End Date changed from 2 Mar 2020 to 9 Mar 2020.