Trials / Completed
CompletedNCT02283762
Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To investigate if Riociguat is effective in the treatment of systemic sclerosis
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Riociguat (Adempas, BAY63-2521) | Starting dose 0.5 mg TID, increase by 0.5 mg every 2 weeks until highest possible dose of 2.5 mg TID |
| DRUG | Placebo | Sham-titration |
Timeline
- Start date
- 2015-01-15
- Primary completion
- 2017-12-15
- Completion
- 2019-03-28
- First posted
- 2014-11-05
- Last updated
- 2020-02-05
- Results posted
- 2019-01-25
Locations
59 sites across 15 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Netherlands, New Zealand, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02283762. Inclusion in this directory is not an endorsement.