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

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

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Macitentan; p = 0.1930 NCT03153137 ↗

Drugs

Indications