At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 262 enrolled
Drug / intervention
Riociguat (Adempas, BAY63-2521) +1 moredrug
Likely dose
Riociguat (Adempas, BAY63-2521) 1 mgfrom 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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
In Brief
A Phase 3 clinical trial evaluating Riociguat (Adempas, BAY63-2521) and Placebo for Pulmonary Hypertension. Completed, enrolled 262 participants across 89 sites in 26 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Russia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedMar 2009
Primary CompletionJun 2012
TodayJul 2026
First PostedMar 4, 2009
Enrollment StartFeb 23, 2009
Primary CompletionJun 27, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.3 years ago
Interventions
Riociguat (Adempas, BAY63-2521)drug
BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.
Placebodrug
Matching Placebo tid orally for 16 weeks