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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02562235
Study type Interventional
Source Bayer
Contact
Status Active, not recruiting
Phase Phase 3
Start date October 29, 2015
Completion date January 27, 2031

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