NCT05167825

A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 3 Months – 15 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of macitentan on hemodynamic measures at Week 24 in pediatric populations.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Macitentan	Macitentan will be administered orally as a tablet.

Timeline

• Start date: 2022-11-14
• Primary completion: 2024-08-23
• Completion: 2025-03-05
• First posted: 2021-12-22
• Last updated: 2025-10-21
• Results posted: 2025-10-21

Locations

11 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study