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Completed

NCT Number: NCT01926847

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

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.

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Key information

Conditions

Raynaud Disease Cardiovascular Diseases Embolism and Thrombosis Livedoid Vasculopathy Peripheral Vascular Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cologne, North Rhine-Westphalia, 50931, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Riociguat (Adempas, BAY63-2521)

Drug

Placebo

Drug

Primary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: 5 weeks

  2. Blood pressure

    Time frame: 5 weeks

  3. Pulse rate

    Time frame: 5 weeks

  4. Incidence of participants showing changes during clinical laboratory and hematology assessment

    Time frame: From baseline to 5 weeks

  5. Plasma concentration at 2 h after riociguat administration

    Time frame: After 2 hours

  6. Placebo corrected change in digital blood flow at room temperature, measured by Laser Doppler Perfusion Imaging

    Time frame: At baseline and after 2h

  7. Placebo corrected change in digital blood flow during cold exposure, measured by Laser Doppler Perfusion Imaging

    Time frame: At baseline and after 2h

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Acronym: DIGIT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2013
Registry last updated
Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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