96
Participants
Start Date
June 14, 2021
Primary Completion Date
July 3, 2025
Study Completion Date
July 3, 2025
Macitentan 10mg
Macitentan 10 mg will be initiated at Day 8 (+/- 3 days) until week 42 (+/- week). The recommended dose is 10 mg once daily by oral administration
Placebo
Placebo 10 mg will be initiated at Day 8 (+/- 3 days) until week 42 (+/- week). The recommended dose is 10 mg once daily by oral administration
Hôpital Bicêtre, Le Kremlin-Bicêtre
Janssen, LP
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER