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:

NCT01926847

EudraCT Number:

2013-001899-38

Study Completed

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
23
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Köln, Germany, 50937

Status
Completed
 

Trial Design