At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 63 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 Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, 12-week Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
In Brief
A Phase 2 clinical trial evaluating Macitentan and Placebo for Pulmonary Hypertension. Completed, enrolled 63 participants across 32 sites in 11 countries.
Detailed Summary
Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension
CountriesAustria, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Spain, Switzerland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartJul 2014
Primary CompletionNov 2015
TodayJul 2026
First PostedFeb 25, 2014
Enrollment StartJul 1, 2014
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.4 years ago
Interventions
Macitentandrug
oral tablet, 10 mg once daily
Placebodrug
matching placebo