At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 202 enrolled
Drug / intervention
Riociguat (Adempas, BAY63-2521) +3 moredrug
Likely dose
Riociguat (Adempas, BAY63-2521) 2 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, Parallel Group, Multi-center Study to Evaluate the Hemodynamic Effects of Riociguat (BAY 63-2521) as Well as Safety and Kinetics in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
In Brief
A Phase 2 clinical trial evaluating Riociguat (Adempas, BAY63-2521) and Placebo for Hypertension, Pulmonary and Ventricular Dysfunction, Left. Completed, enrolled 202 participants across 83 sites in 18 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Canada, China, Czechia, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, Singapore, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2010
Enrollment StartApr 2010
Primary CompletionJun 2012
Study CompletionJul 2025
TodayJul 2026
First PostedFeb 9, 2010
Enrollment StartApr 14, 2010
Primary CompletionJun 6, 2012
Study CompletionJul 23, 2025
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.4 years ago
Interventions
Riociguat (Adempas, BAY63-2521)drug
up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg)
Riociguat (Adempas, BAY63-2521)drug
up to 1 mg three times a day (increasing from 0.5 to 1 mg)
Riociguat (Adempas, BAY63-2521)drug
fixed 0.5 mg three times a day
Placebodrug
Placebo three times a day