A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
Completed · Phase 3
Conditions studied: Pulmonary Arterial Hypertension
In brief
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).
Key facts
- Study ID
- NCT02932410
- Run by
- Actelion
- People needed
- 165
- Starts
- 2017-10-24
- Expected to finish
- 2025-11-27
- Last updated by the study team
- 2026-03-13
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCLA Children's Heart Center — Los Angeles, California, United States
- UCSF Medical Center — San Francisco, California, United States
- Childrens Hospital Colorado — Aurora, Colorado, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- Riley Hospital For Children — Indianapolis, Indiana, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Detroit Medical Center — Detroit, Michigan, United States
- Mayo Clinic - PPDS — Rochester, Minnesota, United States
- Children's Heart Center — Las Vegas, Nevada, United States
- Columbia University Medical Center - PIN — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- East Carolina University — Greenville, North Carolina, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital — Cleveland, Ohio, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Primary Children's Medical Center — Salt Lake City, Utah, United States
- University of Virginia Health System — Charlottesville, Virginia, United States
- Childrens Hospital of Wisconsin — Milwaukee, Wisconsin, United States
- Royal Children's Hospital Melbourne - PIN — Parkville, Australia
- Lady Cilento Children's Hospital — South Brisbane, Australia
- Children's Hospital at Westmead — Westmead, Australia
- Medizinische Universität Graz — Graz, Austria
- Landes Frauen Und Kinderklinik Linz — Linz, Austria
- Phoenix Childrens Hospital — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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