Digital Flow Enhancement in Raynaud's Phenomenon With an sGC (Soluble Guanylate Cyclase) Stimulator

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Raynaud Disease

Intervention / Treatment
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* Drug: Riociguat (Adempas, BAY63-2521)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Riociguat+Placebo<br>Randomization order 1: first single oral dose of 2 mg BAY63-2521, then matching placebo | Drug: Riociguat (Adempas, BAY63-2521)<br> <br> Drug: Placebo<br> <br> |
| Experimental: Placebo+Riociguat<br>Randomization order 2: first matching placebo, then single oral dose of 2 mg BAY63-2521 | Drug: Riociguat (Adempas, BAY63-2521)<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability |  | 5 weeks | 
| Blood pressure |  | 5 weeks | 
| Pulse rate |  | 5 weeks | 
| Incidence of participants showing changes during clinical laboratory and hematology assessment |  | From baseline to 5 weeks | 
| Plasma concentration at 2 h after riociguat administration |  | After 2 hours | 
| Placebo corrected change in digital blood flow at room temperature, measured by Laser Doppler Perfusion Imaging |  | At baseline and after 2h | 
| Placebo corrected change in digital blood flow during cold exposure, measured by Laser Doppler Perfusion Imaging |  | At baseline and after 2h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital ischemia, Raynaud's phenomenon