check_circleStudy Completed

Raynaud Disease

Bayer Identifier:

16787

ClinicalTrials.gov Identifier:

NCT01926847

EudraCT Number:

2013-001899-38

EU CT Number:

Not Available
Digital flow enhancement in Raynaud’s phenomenon with an sGC (soluble guanylate cyclase) stimulator

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.

Key Participants Requirements

Sex

Both

Age

18 - 70 Years
  • - 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
  • - 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
October 2013 - November 2014
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Köln, 50937, Germany

Primary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    5 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Blood pressure
    date_rangeTime Frame:
    5 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Pulse rate
    date_rangeTime Frame:
    5 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of participants showing changes during clinical laboratory and hematology assessment
    date_rangeTime Frame:
    From baseline to 5 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Placebo corrected change in digital blood flow at room temperature, measured by Laser Doppler Perfusion Imaging
    date_rangeTime Frame:
    At baseline and after 2h
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    Safety Issue:
    No
  • Placebo corrected change in digital blood flow during cold exposure, measured by Laser Doppler Perfusion Imaging
    date_rangeTime Frame:
    At baseline and after 2h
    enhanced_encryption
    Safety Issue:
    No

Trial design

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 of a 2 mg IR tablet in 20 patients with Raynaud’s phenomenon (RP)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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