At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 85 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 Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension
In Brief
A Phase 4 clinical trial evaluating Macitentan and Placebo for Portopulmonary Hypertension. Completed, enrolled 85 participants across 52 sites in 7 countries.
Detailed Summary
24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPortopulmonary Hypertension
CountriesBrazil, Czechia, France, Germany, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartJun 2015
Primary CompletionOct 2017
Study CompletionOct 2018
TodayJul 2026
First PostedMar 6, 2015
Enrollment StartJun 23, 2015
Primary CompletionOct 25, 2017
Study CompletionOct 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.3 years ago
Interventions
Macitentandrug
Macitentan film-coated tablet 10 mg once daily.
Placeboother
Matching placebo tablet once daily.