Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)

Phase 1

• Conditions: Hypertension, Pulmonary; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001759-10-GB
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-27
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Male or female patients (18 -75 years of age) with idiopathic, heritable, drug/toxin induced PAH or associated PAH due to congenital heart disease (i.e. atrial septal defects if corrected for more than 12 months) demonstrating insufficient response to treatment with PDE-5i for at least 3 months
• Patients with and without endothelin receptor antagonist (ERA) therapy
• World Health Organization Functional Class (WHO FC) III at screening
• 6-minute walking distance of 165-440 m
• Cardiac index <3.0 L/min/m2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

• All types of PH except subtypes of Dana Point Group I specified in the inclusion criteria
• Evidence of clinically significant restrictive or obstructive parenchymal lung diseases in the judgment of the investigator (e.g. based on a clean CT lung scan).
• Diffusing capacity of the lung for carbon monoxide (DLCO) <30% predicted
• History or active state of serious hemoptysis / pulmonary hemorrhage including those managed by bronchial artery embolization
• Patients unable to perform a valid 6MWD test
•Pregnant women (i.e. positive pregnancy test or other signs of pregnancy), or breast feeding women, or women with childbearing potential not using a combination of 2 effective methods of birth control

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified