clinical trial · NCT02932410
A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
Actelion·phase3·completed·n = 165
Pulmonary Arterial HypertensionMacitentanStandard-of-care
brief summary
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).
started
Oct 24, 2017
primary completion
Aug 28, 2024
completion
Nov 27, 2025
last updated
Mar 13, 2026
official title
A Multicenter, Open-label, Randomized, Study With Single-arm Extension Period to Assess the Pharmacokinetics, Safety and Efficacy of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol