Conditions: Pulmonary Hypertension
Keywords: Chronic thromboembolic pulmonary hypertension PH soluble Guanylate Cyclase Stimulator sGC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 262
Healthy volunteers: no

Brief summary:
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Detailed description:
Adverse event data will be covered in Adverse events section.

Arms:
arm 1: Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks arm 2: Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks

Interventions: intervention 1: Riociguat (Adempas, BAY63-2521) intervention 2: Placebo
Intervention descriptions: intervention 1: BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks. intervention 2: Matching Placebo tid orally for 16 weeks

Protocol document: