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
Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 16 Jun 2017
At a glance
- Drugs Macitentan (Primary)
- Indications Heart disorders
- Focus Registrational; Therapeutic Use
- Acronyms RUBATO
- Sponsors Actelion Pharmaceuticals
- 08 Jun 2017 Planned End Date changed from 23 Jan 2020 to 14 Feb 2020.
- 08 Jun 2017 Planned primary completion date changed from 17 Jan 2020 to 14 Feb 2020.
- 08 Jun 2017 Planned initiation date changed from 10 Aug 2017 to 15 Aug 2017.