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-CZ

Lead Sponsor: Bayer AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

• Male or female patients (18 -75 years of age) with idiopathic, heritable and 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether it is safe, feasible and beneficial to replace PDE-5i therapy with Riociguat in PAH patients demonstrating insufficient response to PDE-5 inhibition.;Secondary Objective: Not applicable;Primary end point(s): There is no primary endpoint in this study. All efficacy variables are exploratory. <br><br>;Timepoint(s) of evaluation of this end point: Not applicable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Change from baseline in 6 minute walking distance.<br>• Change in cardiac index.<br>• Change in N-terminal pro-brain natriuretic peptide.<br>• Change in World Health Organization functional class.<br>• Proportion of patients with clinical worsening.<br>• Change in quality of life EuroQol questionnaire.<br>• Proportion of patients without clinical worsening who achieve at least World Health Organization functional class II and an improvement in 6 minute walking distance of greater than or equal to 30 metres. ;Timepoint(s) of evaluation of this end point: After 12 and 24 weeks (except for change in cardiac index: after 24 weeks only)<br>

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