Trial Condition(s):
Raynaud Disease
Digital flow enhancement in Raynaud’s phenomenon with an sGC (soluble guanylate cyclase) stimulator (DIGIT)
Bayer Identifier:
16787
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Patients with Raynaud's phenomenon suffer from painful attacks triggered by stress or cold causing acute lowering of blood flow through the digits. In this trial the safety and efficacy as well as the effect of one dose of the sGC stimulator Riociguat on digital blood flow will be measured during a cold exposure test in patients suffering from Raynaud's phenomenon. Measurements of two periods will be compared: in one period the patient will be given active drug and in the other period a placebo.
Inclusion Criteria
- Patients suffering from Raynaud’s phenomenon diagnosed at least ≥1 year before beginning of the study of the following origin: -- idiopathic (primary) -- limited cutaneous Scleroderma associated -- diffuse cutaneous Scleroderma associated -- mixed connective tissue disease associated
Exclusion Criteria
- Patients taking medication interfering with the digital flow measurement such as calcium channel blockers (CCB), phosphodiesterase 5 (PDE5) inhibitors, endothelin receptor antagonists (ERA), Nitrates - Smokers - Systolic blood pressure (SBP) below 105mmHg at rest
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Köln, Germany, 50937 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single dose, double-blind, placebo-controlled, single center, randomized cross-over study to investigate safety, tolerability, pharmacodynamics and pharmacokinetic properties of BAY63-2521 after oral dosing of a 2 mg IR tablet in 20 patients with Raynaud’s phenomenon (RP)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilityTimeframe: 5 weeks
- Blood pressureTimeframe: 5 weeks
- Pulse rateTimeframe: 5 weeks
- Incidence of participants showing changes during clinical laboratory and hematology assessmentTimeframe: From baseline to 5 weeks
- Placebo corrected change in digital blood flow at room temperature, measured by Laser Doppler Perfusion ImagingTimeframe: At baseline and after 2h
- Placebo corrected change in digital blood flow during cold exposure, measured by Laser Doppler Perfusion ImagingTimeframe: At baseline and after 2h
Additional Information
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