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

Raynaud Disease Clinical Trial

— DIGIT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926847
• Other study ID #: 16787
• Secondary ID: 2013-001899-38
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2013
• Last updated: June 13, 2014
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Raynaud Disease

Intervention

Drug:
• Riociguat (Adempas, BAY63-2521)

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability		5 weeks	Yes
Primary	Blood pressure		5 weeks	Yes
Primary	Pulse rate		5 weeks	Yes
Primary	Incidence of participants showing changes during clinical laboratory and hematology assessment		From baseline to 5 weeks	Yes
Primary	Plasma concentration at 2 h after riociguat administration		After 2 hours	No
Primary	Placebo corrected change in digital blood flow at room temperature, measured by Laser Doppler Perfusion Imaging		At baseline and after 2h	No
Primary	Placebo corrected change in digital blood flow during cold exposure, measured by Laser Doppler Perfusion Imaging		At baseline and after 2h	No

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