Completed
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 in 20 Patients With Raynaud's Phenomenon (RP)
Led by Bayer · Updated on 2014-06-16
23
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
Digital Flow Enhancement in Raynaud's Phenomenon With an sGC (Soluble Guanylate Cyclase) Stimulator
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
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
You will not qualify if you...
- 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 Site Locations
Total: 1 location
1
Cologne, North Rhine-Westphalia, Germany, 50931
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
N/A
Number of Arms
2
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