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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01926847
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : June 16, 2014
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Raynaud Disease Drug: Riociguat (Adempas, BAY63-2521) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: 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)
Study Start Date : October 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Riociguat+Placebo
Randomization order 1: first single oral dose of 2 mg BAY63-2521, then matching placebo
Drug: Riociguat (Adempas, BAY63-2521)
Drug: Placebo
Experimental: Placebo+Riociguat
Randomization order 2: first matching placebo, then single oral dose of 2 mg BAY63-2521
Drug: Riociguat (Adempas, BAY63-2521)
Drug: Placebo

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01926847

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Köln, Nordrhein-Westfalen, Germany, 50931
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT01926847    
Other Study ID Numbers: 16787
2013-001899-38 ( EudraCT Number )
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014
Keywords provided by Bayer:
Digital ischemia
Raynaud's phenomenon
Additional relevant MeSH terms:
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Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Enzyme Activators
Molecular Mechanisms of Pharmacological Action