At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 226 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.
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome
In Brief
A Phase 3 clinical trial evaluating Macitentan 10 mg and Placebo for Pulmonary Arterial Hypertension. Completed, enrolled 226 participants across 55 sites in 21 countries.
Detailed Summary
Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesAustria, Bulgaria, Chile, China, France, Germany, Greece, Israel, Malaysia, Mexico, Philippines, Poland, Portugal, Romania, Russia, Serbia, Spain, Turkey (Türkiye), United Kingdom, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartMay 2013
Primary CompletionDec 2016
TodayJul 2026
First PostedDec 6, 2012
Enrollment StartMay 21, 2013
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 13.6 years ago
Interventions
Macitentan 10 mgdrug
Macitentan 10 mg oral tablet once daily
Placebodrug
Macitentan-matching placebo oral tablet once daily