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

NCT01926847 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-06-16

No results posted yet for this study

Summary

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

  • Raynaud Disease

Interventions

DRUG

Riociguat (Adempas, BAY63-2521)

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01926847 on ClinicalTrials.gov