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COMPLETED
NCT05167825
PHASE3

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

Sponsor: Janssen Pharmaceutical K.K.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

3 Months - 15 Years

Study Type

INTERVENTIONAL

Enrollment

7

Start Date

2022-11-14

Completion Date

2025-03-05

Last Updated

2026-05-07

Healthy Volunteers

No

Interventions

DRUG

Macitentan

Macitentan will be administered orally as a tablet.

Locations (11)

Nagano Children's Hospital

Azumino-shi, Japan

Institute of Science Tokyo Hospital

Bunkyō City, Japan

Fukuoka Children's Hospital

Fukuoka, Japan

Okayama University Hospital

Okayama, Japan

Toho University Medical Center Omori Hospital

Ōta-ku, Japan

Hokkaido University Hospital

Sapporo, Japan

National Center for Child Health and Development

Setagaya Ku, Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, Japan

National Cerebral and Cardiovascular Center

Suita-Shi, Japan

Osaka University Hospital

Suita-shi, Japan

The University of Tokyo Hospital

Tokyo, Japan