Conditions: Hypertension, Pulmonary Ventricular Dysfunction, Left
Keywords: Pulmonary Hypertension Left ventricular dysfunction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 202
Healthy volunteers: no

Brief summary:
The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Detailed description:
Pharmacokinetics parameters were regarded as exploratory parameters. Adverse event data will be covered in Adverse events section.

Arms:
arm 1: Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg). arm 2: Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg). arm 3: Participants received riociguat 0.5 mg tid (fixed dose). arm 4: Participants received placebo tid.

Interventions: intervention 1: Riociguat (Adempas, BAY63-2521) intervention 2: Riociguat (Adempas, BAY63-2521) intervention 3: Riociguat (Adempas, BAY63-2521) intervention 4: Placebo
Intervention descriptions: intervention 1: up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg) intervention 2: up to 1 mg three times a day (increasing from 0.5 to 1 mg) intervention 3: fixed 0.5 mg three times a day intervention 4: Placebo three times a day

Protocol document: