A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH. - Free study-related medical care provided...
Date First Received: January 23, 2002
Last Updated: June 6, 2008
Verified by: Sanofi-Aventis, June 2008
Clinical Trial Phase: Phase 3 | Start Date: May 2001
Overall Status: Completed
Estimated Enrollment: 1522
Brief Summary
Official Title: “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.”
Condition Keyword(s):
Intervention(s):
A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH. - Free study-related medical care provided.
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Alfuzosin (SL770499)
Outcome Measures for this Clinical Trial
Primary Measures
- occurrence of first episode of acute urinary retention (AUR)
Secondary Measures
- need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)
Criteria for Participation in this Clinical Trial
- 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
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 55 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Sanofi-Aventis
Overall Clinical Trial Officials and Contacts
ICD CSD Study Director Sanofi-Aventis
Related Publications
Citations Reporting Results
Roehrborn CG. Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention: results of a 2-year placebo-controlled study. BJU Int. 2006 Apr;97(4):734-41.
Additional Information
Information obtained from ClinicalTrials.gov on October 15, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00029822
Study ID Number: EFC4485
ClinicalTrials.gov Identifier: NCT00029822
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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