clinical trial · NCT02562235
Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
Bayer·phase3·active not recruiting·n = 24
Hypertension, PulmonaryRiociguat (Adempas, BAY63-2521)
brief 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.
started
Oct 29, 2015
primary completion
Mar 7, 2020
completion
Aug 3, 2027
last updated
Apr 9, 2026
official title
Open-label, Individual Dose Titration Study to Evaluate Safety, Tolerability and Pharmacokinetics of Riociguat in Children From 6 to Less Than 18 Years of Age With Pulmonary Arterial Hypertension (PAH)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol