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

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Bayer

Status and phase

Completed
Phase 2

Conditions

Raynaud Disease

Treatments

Drug: Placebo
Drug: Riociguat (Adempas, BAY63-2521)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01926847
16787
2013-001899-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

23 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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