Riociguat in Children With Pulmonary Arterial Hypertension (PAH)

  • STATUS
    Not Recruiting
  • End date
    Nov 25, 2031
  • participants needed
    23
  • sponsor
    Bayer
Updated on 26 May 2021
Investigator
Bayer Clinical Trials Contact
Primary Contact
National Cerebral and Cardiovascular Center (3.9 mi away) Contact
+51 other location
heart disease
rheumatism
primary pulmonary hypertension
pulmonary arterial hypertension
right heart catheterization
riociguat
left ventricular end-diastolic pressure
adempas
epoprostenol

Summary

This study is 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 consists of two phases: titration phase up to 8 weeks and a maintenance phase up to 16 weeks.

Details
Condition Pulmonary Hypertension
Treatment Riociguat (ADEMPAS, BAY63-2521)
Clinical Study IdentifierNCT02562235
SponsorBayer
Last Modified on26 May 2021

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