At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 142 enrolled
Drug / intervention
Macitentan 10 mg +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.
Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects
In Brief
A Phase 3 clinical trial evaluating Macitentan 10 mg and Placebo for Congenital Heart Disease. Completed, enrolled 142 participants across 32 sites in 12 countries.
Detailed Summary
The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Disease
CountriesAustralia, Canada, China, Czechia, Denmark, France, Germany, New Zealand, Poland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartAug 2017
Primary CompletionJun 2021
Study CompletionJul 2021
TodayJul 2026
First PostedMay 15, 2017
Enrollment StartAug 14, 2017
Primary CompletionJun 30, 2021
Study CompletionJul 26, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 9.1 years ago
Interventions
Macitentan 10 mgdrug
film-coated tablet; oral use
Placebodrug
film-coated tablet; oral use