drugset / Trial / NCT01739400

Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome

NCT01739400 ↗

Phase 3 Terminated 217 enrolled Actelion
NaSingle-groupOpen-labelTreatment

Summary

Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.

Timeline

Start
2013-09-10
Primary completion
2018-01-12
Completion
2018-01-12

Outcome

Outcome not reported

Stopped: “Primary endpoint of parent study AC-055-305/MAESTRO (NCT01743001) not met.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Macitentan Other / unclassified 10 mg —