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NCT02562235 · ClinicalTrials.gov record · last posted 2026-07-01

Riociguat in Children With Pulmonary Arterial Hypertension (PAH)

Study acronym: PATENT-CHILD
StatusActive, Not Recruiting
PhasePhase 3
SponsorBayer
Started2015-10-29
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from the ClinicalTrials.gov record
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.

Amendment record 118 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 118 times since 2015-09-28; most recent amendment 2026-06-30. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2019-12-20
Status change Recruiting→Active, Not Recruitingv47
2015-11-26
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT02562235
Lead Sponsor Bayer
Collaborators: Merck Sharp & Dohme LLC
Conditions Hypertension, Pulmonary
Enrollment 24 participants
Start Date 2015-10-29
Primary Completion 2020-03-07 (estimated)
Study Completion 2027-08-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-01