Clinical Trial: Digital Flow Enhancement in Raynaud's Phenomenon With an sGC (Soluble Guanylate Cyclase) Stimulator
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Bayer
Dates:
Date Received: August 19, 2013
Date Started: October 2013
Date Completion:
Last Updated: June 13, 2014
Last Verified: June 2014
