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

June 13, 2014 updated by: Bayer

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50931

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Riociguat+Placebo
Randomization order 1: first single oral dose of 2 mg BAY63-2521, then matching placebo
Drug: Placebo
Drug: Riociguat (Adempas, BAY63-2521)
Experimental: Placebo+Riociguat
Randomization order 2: first matching placebo, then single oral dose of 2 mg BAY63-2521
Drug: Placebo
Drug: Riociguat (Adempas, BAY63-2521)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: 5 weeks
5 weeks
Blood pressure
Time Frame: 5 weeks
5 weeks
Pulse rate
Time Frame: 5 weeks
5 weeks
Incidence of participants showing changes during clinical laboratory and hematology assessment
Time Frame: From baseline to 5 weeks
From baseline to 5 weeks
Plasma concentration at 2 h after riociguat administration
Time Frame: After 2 hours
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
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
At baseline and after 2h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 19, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 21, 2013

Study Record Updates

Last Update Posted (Estimate)

June 16, 2014

Last Update Submitted That Met QC Criteria

June 13, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16787
  • 2013-001899-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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