Clinical Trial in Males With BPH (Enlarged Prostate)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00029822
Recruitment Status : Completed
First Posted : January 24, 2002
Last Update Posted : June 9, 2008
Information provided by:

January 23, 2002
January 24, 2002
June 9, 2008
May 2001
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occurrence of first episode of acute urinary retention (AUR)
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Complete list of historical versions of study NCT00029822 on Archive Site
need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)
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Clinical Trial in Males With BPH (Enlarged Prostate)
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.

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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Urinary Retention
  • Prostatic Hyperplasia
  • Benign Prostatic Hypertrophy
Drug: Alfuzosin (SL770499)
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2005
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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
Sexes Eligible for Study: Male
55 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Bulgaria,   Canada,   Denmark,   Finland,   Greece,   Hungary,   Israel,   Netherlands,   Norway,   Poland,   Portugal,   Romania,   South Africa,   Spain,   Sweden,   United States
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ICD Study Director, sanofi-aventis
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Study Director: ICD CSD Sanofi
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP