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

NCT ID: NCT01926847

Last Updated: 2014-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Raynaud Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Riociguat+Placebo

Randomization order 1: first single oral dose of 2 mg BAY63-2521, then matching placebo

Group Type EXPERIMENTAL

Riociguat (Adempas, BAY63-2521)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Placebo+Riociguat

Randomization order 2: first matching placebo, then single oral dose of 2 mg BAY63-2521

Group Type EXPERIMENTAL

Riociguat (Adempas, BAY63-2521)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Riociguat (Adempas, BAY63-2521)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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2013-001899-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16787

Identifier Type: -

Identifier Source: org_study_id

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