NCT01291199

Brief Summary

The purpose of this study is to determine whether vardenafil is effective in improving clinical symptoms and peripheral blood flow in patients with primary and secondary Raynaud phenomenon.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2006

Typical duration 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

Study Start

First participant enrolled

November 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2011

Completed
Last Updated

February 8, 2011

Status Verified

January 1, 2011

Enrollment Period

2.8 years

First QC Date

February 1, 2011

Last Update Submit

February 7, 2011

Conditions

Raynaud Syndrome

Keywords

double-blind placebo controlled cross-over study

Outcome Measures

Primary Outcomes (1)

  • Change in the Raynaud's Condition Score

    The Raynaud's Condition Score (RCS) is a clinically validated scale used to determine the difficulty that patients experience with Raynaud's phenomenon, and is closely associated with the measures of disability and overall impact and activity of the disease.

    daily for 18 weeks

Secondary Outcomes (2)

  • Number of participants with adverse events as a Measure of Safety and Tolerability

    daily for 18 weeks

  • Digital blood flow

    at baseline, one hour after drug intake and after six weeks on therapy

Study Arms (2)

Vardenafil 10 mg bid

EXPERIMENTAL
Drug: vardenafilDrug: Placebo

Placebo

PLACEBO COMPARATOR
Drug: vardenafilDrug: Placebo

Interventions

vardenafilDRUG

10 mg p.o. bid for 6 weeks

Also known as: Levitra
PlaceboVardenafil 10 mg bid
PlaceboDRUG

Placebo p.o. 6 weeks bid

PlaceboVardenafil 10 mg bid

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • raynaud-syndrome (primary or secondary) \> 1 year duration
  • age ≥ 18 years; ≤ 80 years
  • informed consent
  • a negative pregnancy test in women of child-bearing age

You may not qualify if:

  • any unstable organic, psychiatric or addictive disease, which - in the opinion of the investigators - might result in an unsuccessful / unreliable participation or premature termination of the trial
  • known contraindications against PDE 5-inhibitors (such as intolerance, therapy with nitrates or inhibitors of CYP3A4, etc.)
  • extensive necrosis of the finger tips
  • pigmentary retinopathy
  • verification as a HbsAg or hepatitis C carrier
  • unstable angina
  • heart failure (NYHA III or IV)
  • valve defects of higher degree (particularly aortic stenosis and hypertrophic obstructive cardiomyopathy)
  • myocardial infarction, stroke or life-threatening cardiac arrhythmias within the last 6 months
  • uncontrolled atrial fibrillation / -flutter with a heart rate \> 100 bpm
  • prolonged QTc-interval (\> 450 msec)
  • congenital long-QT-syndrome
  • hypokalemia
  • severe acute or chronic liver disease, which might lead to priapism (sickle cell anemia, leucemia)
  • hemophilia
  • +34 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cologne - Heart Center

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Related Publications (1)

  • Caglayan E, Huntgeburth M, Karasch T, Weihrauch J, Hunzelmann N, Krieg T, Erdmann E, Rosenkranz S. Phosphodiesterase type 5 inhibition is a novel therapeutic option in Raynaud disease. Arch Intern Med. 2006 Jan 23;166(2):231-3. doi: 10.1001/archinte.166.2.231.

    PMID: 16432094BACKGROUND

MeSH Terms

Conditions

Raynaud Disease

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Stephan Rosenkranz, MD

    University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 8, 2011

Study Start

November 1, 2006

Primary Completion

August 1, 2009

Study Completion

April 1, 2010

Last Updated

February 8, 2011

Record last verified: 2011-01

Locations

DE(1)