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 approved dosages of phosphodiesterase-5 inhibitors (PDE-5i)
- Conditions
- Hypertension, PulmonaryTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-001759-10-IT
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 61
• Male or female patients (18 -70 years of age) with idiopathic, familial and drug/toxin induced PAH demonstrating insufficient response to treatment with approved dosages of 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 <2.5 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
• All types of PH except subtypes of Dana Point Group I specified in the inclusion criteria
• Moderate to severe bronchial asthma or COPD (forced expiratory volume <60% predicted).
• Moderate to severe restrictive lung disease Total Lung Capacity (TLC) < 70% predicted
• Diffusing capacity of the lung for carbon monoxide (DLCO) <40% 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method