Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients (18 -75 years of age) with idiopathic, familial, drug/toxin induced and associated PAH due to congenital heart disease (Group I / Dana Point Classification of PH) 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 (6MWD) of 165-440 m
Cardiac index \<3.0 L/min/m\*2.
Evidence of clinically significant restrictive or obstructive parenchymal lung diseases
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, for example a combination of condoms with a safe and highly effective contraception method (prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) or a double barrier method is used throughout the study.
Clareo Health | Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor