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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
23
Unnamed facility
Cologne, North Rhine-Westphalia, Germany
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 5 weeks
Blood pressure
Time frame: 5 weeks
Pulse rate
Time frame: 5 weeks
Incidence of participants showing changes during clinical laboratory and hematology assessment
Time frame: From baseline to 5 weeks
Plasma concentration at 2 h after riociguat administration
Time frame: After 2 hours
Placebo corrected change in digital blood flow at room temperature, measured by Laser Doppler Perfusion Imaging
Time frame: At baseline and after 2h
Placebo corrected change in digital blood flow during cold exposure, measured by Laser Doppler Perfusion Imaging
Time frame: At baseline and after 2h
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