CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 165 enrolled
Drug / intervention
Macitentan +1 moredrug
Likely dose
Not stated in 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.

Search/NCT02932410
NCT02932410Phase 3Completed
CompareCT.gov

A Multicenter, Open-label, Randomized, Study With Single-arm Extension Period to Assess the Pharmacokinetics, Safety and Efficacy of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension

Actelion·interventional·Posted Oct 13, 2016·Updated Mar 13, 2026

In Brief

A Phase 3 clinical trial evaluating Macitentan and Standard-of-care for Pulmonary Arterial Hypertension. Completed, enrolled 165 participants across 85 sites in 23 countries.

Detailed Summary

This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with pulmonary arterial hypertension (PAH).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesAustralia, Austria, Brazil, Canada, China, Colombia, Finland, France, Hungary, Israel, Malaysia, Mexico, Philippines, Poland, Portugal, Russia, South Africa, South Korea, Spain, Thailand, Ukraine, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 13, 2016
Enrollment StartOct 24, 2017
Primary CompletionAug 28, 2024
Study CompletionNov 27, 2025
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 9.7 years ago

Interventions

Macitentandrug

Dispersible tablet; Oral use

Standard-of-careother

Standard-of-care as per site's clinical practice which may comprise treatment with PAH non-specific treatment and/or up to two PAH-specific medications excluding macitentan and IV/SC prostanoids.