Initial Dual Oral Combination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

June 14, 2021

Primary Completion Date

July 3, 2025

Study Completion Date

July 3, 2025

Conditions
Thromboembolic Pulmonary HypertensionChronic DiseaseInoperable Disease
Interventions
DRUG

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

DRUG

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

Trial Locations (1)

94270

Hôpital Bicêtre, Le Kremlin-Bicêtre

All Listed Sponsors
collaborator

Janssen, LP

INDUSTRY

lead

Assistance Publique - Hôpitaux de Paris

OTHER