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A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension
Sponsor: Janssen Pharmaceutical K.K.
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
Conditions
Interventions
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