Hypertension, Pulmonary
Conditions
Keywords
Chronic thromboembolic pulmonary hypertension
Brief summary
The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.
Interventions
Individual dosing of riociguat between 0.5 and 2.5 mg three times daily based on patient's well being and blood pressure. (The individual optimal dose should be determined during the initial 8-week titration phase based on patient's monitoring of systolic blood pressure and well-being.)
Sponsors
Bayer
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
\- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery
Exclusion criteria
* All types of pulmonary hypertension other than Dana Point Classification Group 4 * Operable patients listed for PEA (Pulmonary Endarterectomy)
Countries
Austria, Belgium, Canada, Colombia, Czechia, Denmark, France, Germany, Italy, Japan, Mexico, Netherlands, Portugal, Russia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed