Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (EAS)

Bayer

Status

Conditions: Hypertension, Pulmonary

Treatments: Drug: Adempas (Riociguat, BAY63-2521)

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT01784562

2012-002104-40 (EudraCT Number)

16097

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)