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

Phase 2

Completed

• Conditions: Raynaud Disease
• Interventions: Drug: Riociguat (Adempas, BAY63-2521); Drug: Placebo

• Registration Number: NCT01926847
• Lead Sponsor: Bayer

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-21
• Study Start: 2013-10
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-13
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Riociguat+Placebo	Placebo	Randomization order 1: first single oral dose of 2 mg BAY63-2521, then matching placebo
Riociguat+Placebo	Riociguat (Adempas, BAY63-2521)	Randomization order 1: first single oral dose of 2 mg BAY63-2521, then matching placebo
Placebo+Riociguat	Riociguat (Adempas, BAY63-2521)	Randomization order 2: first matching placebo, then single oral dose of 2 mg BAY63-2521
Placebo+Riociguat	Placebo	Randomization order 2: first matching placebo, then single oral dose of 2 mg BAY63-2521

Primary Outcome Measures

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