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

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ClinicalTrials.gov Identifier: NCT01926847
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Riociguat
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01926847


Locations
Germany
Köln, Nordrhein-Westfalen, Germany, 50931
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01926847     History of Changes
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:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases