NCT01926847

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

August 19, 2013

Last Update Submit

June 13, 2014

Conditions

Raynaud Disease

Keywords

Digital ischemiaRaynaud's phenomenon

Outcome Measures

Primary Outcomes (7)

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

    5 weeks

  • Blood pressure

    5 weeks

  • Pulse rate

    5 weeks

  • Incidence of participants showing changes during clinical laboratory and hematology assessment

    From baseline to 5 weeks

  • Plasma concentration at 2 h after riociguat administration

    After 2 hours

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

    At baseline and after 2h

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

    At baseline and after 2h

Study Arms (2)

Riociguat+Placebo

EXPERIMENTAL

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

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

Placebo+Riociguat

EXPERIMENTAL

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

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

Interventions

Riociguat (Adempas, BAY63-2521)DRUG
Placebo+RiociguatRiociguat+Placebo
PlaceboDRUG
Placebo+RiociguatRiociguat+Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Cologne, North Rhine-Westphalia, 50931, Germany

Location

MeSH Terms

Conditions

Raynaud Disease

Interventions

riociguat

Condition Hierarchy (Ancestors)

Livedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations

DE(1)