At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 143 enrolled
Drug / intervention
Macitentan +1 moredrug
Likely dose
Macitentan 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Macitentan and Placebo for Heart Failure With Preserved Ejection Fraction. Completed, enrolled 143 participants across 95 sites in 17 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Austria, Brazil, Bulgaria, Czechia, Denmark, France, Germany, Hungary, Israel, Poland, Romania, Russia, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartJul 2017
Primary CompletionMar 2021
TodayJul 2026
First PostedMay 15, 2017
Enrollment StartJul 11, 2017
Primary CompletionMar 12, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9.1 years ago
Interventions
Macitentandrug
macitentan 10 mg; film-coated tablet; oral use
Placebodrug
film-coated tablet (identical to the macitentan tablet); oral use