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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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19 February 2015 |
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Main ID: |
NCT00029822 |
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Date of registration:
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23/01/2002 |
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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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Clinical Trial in Males With BPH (Enlarged Prostate)
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Scientific title:
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Long-Term, Efficacy and Safety of Alfuzosin 10 MG OD on the Risk of Acute Urinary Retention and the Need for Surgery in Patients With BPH. A Two Year, Randomized, Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Study. |
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Date of first enrolment:
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May 2001 |
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Target sample size:
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1522 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00029822 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Bulgaria
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Canada
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Denmark
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Finland
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Greece
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Hungary
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Israel
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Netherlands
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Norway
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Poland
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Portugal
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Romania
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South Africa
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Spain
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Sweden
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United States
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Contacts
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Name:
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ICD CSD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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- Has been suffering for at least 6 months with any of the following symptoms:
- daytime or nighttime urinary frequency
- urgent feeling to urinate
- difficulty starting urinary stream
- interruption of urinary stream
- feeling of incomplete urination
- Has not had a previous episode of acute urinary retention
- Has not been diagnosed with prostate cancer
- Has not had previous prostate surgery
- Is not an insulin-dependent diabetic
Age minimum:
55 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostatic Hyperplasia
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Urinary Retention
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Benign Prostatic Hypertrophy
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Intervention(s)
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Drug: Alfuzosin (SL770499)
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Primary Outcome(s)
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occurrence of first episode of acute urinary retention (AUR)
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Secondary Outcome(s)
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need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)
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Secondary ID(s)
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EFC4485
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SL770499
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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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