Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
Status:
Active, not recruiting
Trial end date:
2031-11-25
Target enrollment:
Participant gender:
Summary
This study was designed to evaluate the safety, tolerability, pharmacodynamics and
pharmacokinetics of riociguat at age-, sex- and body-weight-adjusted doses of 0.5 mg, 1.0 mg,
1.5 mg, 2.0 mg and 2.5 mg TID in children from ≥6 to less than 18 years with pulmonary
arterial hypertension (PAH) group 1. The study design consisted of a main study part followed
by an optional long-term extension part. The main treatment period consisted of two phases:
titration phase up to 8 weeks and a maintenance phase up to 16 weeks.