[Translation] A multicenter, open-label, randomized study with a single-arm extension to evaluate the pharmacokinetics, safety, and efficacy of macitentan compared with standard care in children with pulmonary arterial hypertension
研究的主要目的是在PAH 儿童中评估马昔腾坦的PK。次要目的是评估马昔腾坦在PAH儿童中的安全性和耐受性。评估PAH儿童中马昔腾坦的疗效。
[Translation] The primary objective of the study was to evaluate the PK of macitentan in children with PAH. A secondary objective was to evaluate the safety and tolerability of macitentan in children with PAH. To evaluate the efficacy of macitentan in children with PAH.