drugset / Trial / NCT03153137

Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects

NCT03153137

Phase 3 Completed 142 enrolled Actelion
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.

Timeline

Start
2017-08-14
Primary completion
2021-06-30
Completion
2021-07-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Macitentan Other / unclassified 10 mg Oral