At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 121 enrolled
Drug / intervention
Riociguat (Adempas, BAY63-2521) +1 moredrug
Likely dose
Riociguat (Adempas, BAY63-2521) 0.5 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.
A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
In Brief
A Phase 2 clinical trial evaluating Riociguat (Adempas, BAY63-2521) and Placebo for Scleroderma, Systemic. Completed, enrolled 121 participants across 59 sites in 15 countries.
Detailed Summary
To investigate if Riociguat is effective in the treatment of systemic sclerosis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScleroderma, Systemic
CountriesAustralia, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Netherlands, New Zealand, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartJan 2015
Primary CompletionDec 2017
Study CompletionMar 2019
TodayJul 2026
First PostedNov 5, 2014
Enrollment StartJan 15, 2015
Primary CompletionDec 15, 2017
Study CompletionMar 28, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.7 years ago
Interventions
Riociguat (Adempas, BAY63-2521)drug
Starting dose 0.5 mg TID, increase by 0.5 mg every 2 weeks until highest possible dose of 2.5 mg TID
Placebodrug
Sham-titration