Digital Flow Enhancement in Raynaud's Phenomenon With an sGC (Soluble Guanylate Cyclase) Stimulator
NCT ID: NCT01926847
Last Updated: 2014-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2013-10-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
QUADRUPLE
Study Groups
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Riociguat+Placebo
Randomization order 1: first single oral dose of 2 mg BAY63-2521, then matching placebo
Riociguat (Adempas, BAY63-2521)
Placebo
Placebo+Riociguat
Randomization order 2: first matching placebo, then single oral dose of 2 mg BAY63-2521
Riociguat (Adempas, BAY63-2521)
Placebo
Interventions
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Riociguat (Adempas, BAY63-2521)
Placebo
Eligibility Criteria
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Inclusion Criteria
* idiopathic (primary)
* limited cutaneous Scleroderma associated
* diffuse cutaneous Scleroderma associated
* mixed connective tissue disease associated
Exclusion Criteria
* Smokers
* Systolic blood pressure (SBP) below 105mmHg at rest
18 Years
70 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Cologne, North Rhine-Westphalia, Germany
Countries
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Other Identifiers
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2013-001899-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16787
Identifier Type: -
Identifier Source: org_study_id
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