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

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01291199
First received: February 1, 2011
Last updated: February 7, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Raynaud Syndrome
Drug: vardenafil
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Change in the Raynaud's Condition Score [ Time Frame: daily for 18 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of participants with adverse events as a Measure of Safety and Tolerability [ Time Frame: daily for 18 weeks ] [ Designated as safety issue: Yes ]
  • Digital blood flow [ Time Frame: at baseline, one hour after drug intake and after six weeks on therapy ] [ Designated as safety issue: No ]
    digital blood flow measured with laser doppler


Enrollment: 57
Study Start Date: November 2006
Study Completion Date: April 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vardenafil 10 mg bid Drug: vardenafil
10 mg p.o. bid for 6 weeks
Other Name: Levitra
Drug: Placebo
Placebo p.o. 6 weeks bid
Placebo Comparator: Placebo Drug: vardenafil
10 mg p.o. bid for 6 weeks
Other Name: Levitra
Drug: Placebo
Placebo p.o. 6 weeks bid

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291199

Locations
Germany
University of Cologne - Heart Center
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Stephan Rosenkranz, MD University of Cologne
  More Information

Publications:
Responsible Party: Prof. Dr. med. Erland Erdmann, Universität zu Köln
ClinicalTrials.gov Identifier: NCT01291199     History of Changes
Other Study ID Numbers: Ro-002/05, 2005-000295-41
Study First Received: February 1, 2011
Last Updated: February 7, 2011
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
double-blind placebo controlled cross-over study

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vardenafil
Phosphodiesterase 5 Inhibitors
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on July 31, 2014