At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 7 enrolled
Drug / intervention
Macitentandrug
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.
A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of Macitentan in Japanese Pediatric Patients (>=3 Months to <15 Years) With Pulmonary Arterial Hypertension
In Brief
A Phase 3 clinical trial evaluating Macitentan for Pulmonary Arterial Hypertension. Completed, enrolled 7 participants across 11 sites.
Detailed Summary
The purpose of this study is to evaluate the effect of macitentan on hemodynamic measures at Week 24 in pediatric populations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedDec 2021
Enrollment StartNov 2022
Primary CompletionAug 2024
Study CompletionMar 2025
TodayJul 2026
First PostedDec 22, 2021
Enrollment StartNov 14, 2022
Primary CompletionAug 23, 2024
Study CompletionMar 5, 2025
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.5 years ago
Interventions
Macitentandrug
Macitentan will be administered orally as a tablet.