Effects of Vardenafil on Clinical Symptoms and Peripheral Blood Flow in Patients With Raynaud's Syndrome

February 7, 2011 updated by: University of Cologne

Double-blind, Placebo-controlled Cross-over Study to Investigate the Effects of the Phosphodiesterase 5-inhibitor Vardenafil on Periphery Blood Flow and Clinical Symptoms of Patients With Raynaud's Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • NRW
      • Cologne, NRW, Germany, 50924
        • University of Cologne - Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • active peptic ulcers
  • arterial hypotension (systolic blood pressure at rest <90 mmHg) or
  • arterial hypertension(systolic blood pressure at rest >170 mmHg or diastolic blood pressure at rest >110 mmHg)
  • malignancy within the last 5 years (except squamous or basal cell skin cancer)
  • patients with injuries of the spinal cord or central nervous system
  • patients with severe chronic kidney disease (creatinin clearance < 30 ml)
  • patients with mild to severe liver disease (Child-Pugh A-C)
  • Age below 18 or above 80
  • prohibited concomitant medication during the study:

    • nitrates or other NO-donators (including amylnitrit)
    • anticoagulative drugs except inhibitors of thrombocyte function
    • androgens (such as testosterone) or anti-androgens
    • strong inhibitors of cytochrome P4503A4:
  • very potent HIV-Protease-inhibitors (ritonavir, indinavir)
  • anti-mycotic like itraconazole and ketoconazole (topical applications are allowed)
  • erythromycin
  • grapefruit-juice or products containing grapefruit-juice

    • other study medications (including placebo) up to 30 days before study inclusion
    • therapy of erectile dysfunction(including sildenafil, sublingual apomorphin, MUSE®, intracavernous injections or vacuum pumps) or other therapies of erectile dysfunction within 4 weeks and during the trial period
    • nebivolol
    • alpha-blockers
    • Calcium antagonists
    • medications prolonging the QT-interval
    • abnormal lab tests like:
  • serum-creatinine > 3 mg/dl at visit 1
  • GOT and GPT > 3 x reference limit set
  • diabetes mellitus with a HbA1c > 9%
  • patients who are not willing to disclaim a therapy of their erectile dysfunction with vacuum pumps, intravenous injections, sildenafil or other therapies during the trial
  • severe migraine (more than once a moth during the last 6 months)
  • intolerance to the study medication
  • patients who are not able to understand the information and informed consent due to a mental disorder or linguistic barriers
  • persons who are living in a institution directly under federal government control due to a court order
  • patients who refuse to renounce drinking grapefruit juice during the trial
  • women who are pregnant or lactating
  • women who are not protected from a pregnancy (intake of oral contraceptives alone in insufficient; highly effective methods of birth control have to be used with a failure rate <1%; barriers: implants, intrauterine-devices (IUD´s),diaphragm, condoms, abstinence, partner is vasectomized, spermicides)
  • patients who participated in other interventional studies within 30 days of study inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
10 mg p.o. bid for 6 weeks
Other Names:
  • Levitra
Placebo p.o. 6 weeks bid
Experimental: Vardenafil 10 mg bid
10 mg p.o. bid for 6 weeks
Other Names:
  • Levitra
Placebo p.o. 6 weeks bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Raynaud's Condition Score
Time Frame: daily for 18 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events as a Measure of Safety and Tolerability
Time Frame: daily for 18 weeks
daily for 18 weeks
Digital blood flow
Time Frame: at baseline, one hour after drug intake and after six weeks on therapy
digital blood flow measured with laser doppler
at baseline, one hour after drug intake and after six weeks on therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stephan Rosenkranz, MD, University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 1, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (Estimate)

February 8, 2011

Study Record Updates

Last Update Posted (Estimate)

February 8, 2011

Last Update Submitted That Met QC Criteria

February 7, 2011

Last Verified

January 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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