Trials / Completed
CompletedNCT03153111
A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
A Multi-center, Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 143 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease. The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Macitentan | macitentan 10 mg; film-coated tablet; oral use |
| DRUG | Placebo | film-coated tablet (identical to the macitentan tablet); oral use |
Timeline
- Start date
- 2017-07-11
- Primary completion
- 2021-03-12
- Completion
- 2021-03-12
- First posted
- 2017-05-15
- Last updated
- 2025-03-30
- Results posted
- 2022-04-04
Locations
95 sites across 17 countries: United States, Argentina, Austria, Brazil, Bulgaria, Czechia, Denmark, France, Germany, Hungary, Israel, Poland, Romania, Russia, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03153111. Inclusion in this directory is not an endorsement.