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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001899-38 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riociguat+Placebo | Experimental | Randomization order 1: first single oral dose of 2 mg BAY63-2521, then matching placebo |
|
| Placebo+Riociguat | Experimental | Randomization order 2: first matching placebo, then single oral dose of 2 mg BAY63-2521 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat (Adempas, BAY63-2521) | Drug |
| ||
| Placebo |
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cologne | North Rhine-Westphalia | 50931 | Germany |
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| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| ID | Term |
|---|---|
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C542595 | riociguat |
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| Drug |
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |