A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
NCT00810693 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 445
Last updated 2023-11-22
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).
Conditions
- Pulmonary Hypertension
Interventions
- DRUG
-
Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
- DRUG
-
Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1.5mg tid orally for 12 weeks
- DRUG
-
Matching Placebo tid orally for 12 weeks
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-12-17
- Primary Completion
- 2012-05-14
- Completion
- 2012-05-14
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- China
- Czechia
- Denmark
- France
- Germany
- Greece
- Israel
- Italy
- Japan
- Mexico
- New Zealand
- Poland
- Portugal
- Russia
- Singapore
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Thailand
- Turkey (Türkiye)
- United Kingdom
Study Locations
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