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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01926847
First received: August 19, 2013
Last updated: June 13, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
  • Pulse rate [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of participants showing changes during clinical laboratory and hematology assessment [ Time Frame: From baseline to 5 weeks ] [ Designated as safety issue: Yes ]
  • Plasma concentration at 2 h after riociguat administration [ Time Frame: After 2 hours ] [ Designated as safety issue: No ]
  • Placebo corrected change in digital blood flow at room temperature, measured by Laser Doppler Perfusion Imaging [ Time Frame: At baseline and after 2h ] [ Designated as safety issue: No ]
  • Placebo corrected change in digital blood flow during cold exposure, measured by Laser Doppler Perfusion Imaging [ Time Frame: At baseline and after 2h ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926847

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01926847     History of Changes
Other Study ID Numbers: 16787, 2013-001899-38
Study First Received: August 19, 2013
Last Updated: June 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Digital ischemia
Raynaud's phenomenon

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014