At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 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.
Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
In Brief
A Phase 2 clinical trial evaluating Macitentan and Placebo for Chronic Thromboembolic Pulmonary Hypertension. Completed, enrolled 80 participants across 36 sites in 16 countries.
Detailed Summary
Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, China, Czechia, France, Germany, Hungary, Lithuania, Mexico, Poland, Russia, South Korea, Switzerland, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartAug 2014
Primary CompletionSep 2016
TodayJul 2026
First PostedDec 27, 2013
Enrollment StartAug 20, 2014
Primary CompletionSep 28, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.5 years ago
Interventions
Macitentandrug
Macitentan 10 mg, oral tablet, to be taken once daily.
Placebodrug
Matching placebo oral tablet, to be taken once daily.