- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01291199
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
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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:
Placebo p.o. 6 weeks bid
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Experimental: Vardenafil 10 mg bid
|
10 mg p.o. bid for 6 weeks
Other Names:
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
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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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Disease
- Peripheral Vascular Diseases
- Syndrome
- Raynaud Disease
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Vardenafil Dihydrochloride
Other Study ID Numbers
- Ro-002/05
- 2005-000295-41 (EudraCT Number)
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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