clinical trial · NCT04273945
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
Pulmonary Arterial HypertensionMacitentan 10 mgMacitentan 37.5 mgMacitentan 75 mgPlacebo
brief summary
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.
started
Jun 30, 2020
primary completion
Oct 7, 2025
completion
Feb 20, 2029
last updated
Jun 5, 2026
official title
A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol