Trials / Active Not Recruiting
Active Not RecruitingNCT04273945
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 935 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 | Placebo | Participants will receive matching placebo film-coated tablets orally. |
Timeline
- Start date
- 2020-06-30
- Primary completion
- 2025-10-07
- Completion
- 2029-02-20
- First posted
- 2020-02-18
- Last updated
- 2026-04-13
Locations
274 sites across 42 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04273945. Inclusion in this directory is not an endorsement.