Trial intelligence / Profile preview

Macitentan in Fontan-palliated adults and adolescents

2016-003320-23Phase 3Unknown

Sponsor
Actelion Pharmaceuticals Ltd
Start
May 2017
Modality
Small Molecules
Countries
1
01

Overview

Phase 3, randomised, double-blind trial in Single Ventricle Heart Defects, Fontan circulation and Cardiovascular Malformation (CVM) comparing Macitentan with Placebo (2 arms). Primary endpoints: Change in peak VO2 and Change in long-term peak VO2 over 52 weeks. Status: unknown.

02

Drugs

macitentan
03

Conditions

Single Ventricle Heart DefectsFontan circulationCardiovascular Malformation (CVM)

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