Long Term, Single-arm, Open-label Extension Study of Protocol AC-055-305 to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome
Phase of Trial: Phase III
Latest Information Update: 17 Apr 2019
At a glance
- Drugs Macitentan (Primary)
- Indications Eisenmenger complex
- Focus Adverse reactions
- Acronyms MAESTRO-OL
- Sponsors Actelion Pharmaceuticals
- 17 Aug 2018 Status changed to discontinued as the parent study AC-055-305/MAESTRO (NCT01743001) did not meet its primary endpoint, the sponsor decided to prematurely terminate this open-label study.
- 11 Jan 2018 Planned End Date changed from 30 Nov 2017 to 15 Jan 2018.
- 11 Jan 2018 Planned primary completion date changed from 30 Nov 2017 to 15 Jan 2018.