Conditions: Pulmonary Hypertension
Keywords: Pulmonary arterial hypertension PH Stimulator
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 445
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 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

Detailed description:

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 12 weeks arm 2: Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks arm 3: Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks

Interventions: intervention 1: Riociguat (Adempas, BAY63-2521) intervention 2: Riociguat (Adempas, BAY63-2521) intervention 3: Placebo
Intervention descriptions: intervention 1: BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks intervention 2: BAY63-2521: 1.5mg tid orally for 12 weeks intervention 3: Matching Placebo tid orally for 12 weeks

Protocol document: