NCT02562235

Riociguat in Children With Pulmonary Arterial Hypertension (PAH)

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	Riociguat (Adempas, BAY63-2521)	For children with body-weight \<50 kg at screening: body-weight adjusted dose equivalent to the exposure of (0.5 mg) 1.0 - 2.5 mg three times a day, IDT in adults treated for PAH; oral suspension. For children ≥50 kg at screening: 1.0 to 2.5 mg three times a day; oral tablet.

Timeline

• Start date: 2015-10-29
• Primary completion: 2020-03-07
• Completion: 2027-08-03
• First posted: 2015-09-29
• Last updated: 2026-04-09
• Results posted: 2021-05-17

Locations

16 sites across 9 countries: Colombia, Germany, Hungary, Italy, Japan, Mexico, Poland, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study