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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01926847
First Posted: August 21, 2013
Last Update Posted: June 16, 2014
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.
Information provided by (Responsible Party):
Bayer
  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.

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

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

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

Enrollment: 23
Study Start Date: October 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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 Submitted: August 19, 2013
First Posted: August 21, 2013
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