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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 October 2016 |
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Main ID: |
NCT01106118 |
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Date of registration:
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16/04/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Therapeutic Effectiveness of Vardenafil in Patients With Erectile Dysfunction and Metabolic Syndrome in Daily Clinical Practice
REVITALISE |
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Scientific title:
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Therapeutic Effectiveness of Vardenafil in ED Patients With the Metabolic Syndrome in Daily Clinical Practice |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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2289 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01106118 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Egypt
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Israel
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Jordan
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Kazakhstan
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Korea, Republic of
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Kyrgyzstan
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Lebanon
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Libyan Arab Jamahiriya
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Russian Federation
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Saudi Arabia
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Singapore
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Ukraine
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Vietnam
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Yemen
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Erectile Dysfunction (ED) patient who has newly been prescribed vardenafil (Levitra
film-coated tablet) in accordance with the terms of the local marketing
authorization.
- Diagnosis of erectile dysfunction at the discretion of the physician, based on the
patients ED history.
- No use of any Phosphodiesterase Type 5 (PDE5) inhibitor within 1 month of study
entry.
- Documented Metabolic Syndrome (MetS), preferably according to the definition of the
International Diabetes Foundation.
Exclusion Criteria:
- Do not follow the contraindications and warnings of the Summary of Product
Characteristics.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Erectile Dysfunction
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Intervention(s)
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Drug: Vardenafil (Levitra, BAY38-9456)
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Primary Outcome(s)
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The percentage of patients with a clinically relevant, intra-individual improvement in erectile function defined as an increase of 4 points in the erectile function domain of the International Index of Erectile Function (IIEF)
[Time Frame: After approx 12 weeks]
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Secondary Outcome(s)
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Optional by country, the effect of vardenafil on health-related quality of life (HRQoL) using the Aging Males Symptoms (AMS) Scale
[Time Frame: After approx. 12 weeks]
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Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks
[Time Frame: After approx. 12 weeks]
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Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks
[Time Frame: After approx. 12 weeks]
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Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks
[Time Frame: After approx. 12 weeks]
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Secondary ID(s)
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LV0901
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14872
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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