Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
NCT04273945 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 935
Last updated 2026-04-13
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.
Conditions
Interventions
- DRUG
-
Macitentan 10 mg
Participants will receive macitentan 10 mg film-coated tablets orally.
- DRUG
-
Macitentan 37.5 mg
Participants will receive macitentan 37.5 mg film-coated tablets orally.
- DRUG
-
Macitentan 75 mg
Participants will receive macitentan 75 mg film-coated tablets orally.
- DRUG
-
Participants will receive matching placebo film-coated tablets orally.
Sponsors & Collaborators
-
Actelion
lead INDUSTRY
Principal Investigators
-
Actelion Clinical Trials · Actelion
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-30
- Primary Completion
- 2025-10-07
- Completion
- 2029-02-20
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belarus
- Belgium
- Brazil
- Bulgaria
- Canada
- China
- Colombia
- Czechia
- Denmark
- France
- Germany
- Greece
- Hungary
- India
- Israel
- Italy
- Japan
- Malaysia
- Mexico
- Netherlands
- Norway
- Poland
- Portugal
- Russia
- Saudi Arabia
- Serbia
- Singapore
- Slovakia
- South Africa
- South Korea
- Spain
- Sweden
- Taiwan
- Thailand
- Turkey (Türkiye)
- Ukraine
- United Kingdom
- Vietnam
Study Locations
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