At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 445 enrolled
Drug / intervention
Riociguat (Adempas, BAY63-2521) +2 moredrug
Likely dose
Riociguat (Adempas, BAY63-2521) 1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)
In Brief
A Phase 3 clinical trial evaluating Riociguat (Adempas, BAY63-2521) and Placebo for Pulmonary Hypertension. Completed, enrolled 445 participants across 122 sites in 30 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension
CountriesArgentina, 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, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2008
First PostedDec 2008
Primary CompletionMay 2012
TodayJul 2026
First PostedDec 18, 2008
Enrollment StartDec 17, 2008
Primary CompletionMay 14, 2012
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.5 years ago
Interventions
Riociguat (Adempas, BAY63-2521)drug
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
Riociguat (Adempas, BAY63-2521)drug
BAY63-2521: 1.5mg tid orally for 12 weeks
Placebodrug
Matching Placebo tid orally for 12 weeks