Clinical Trial in Males With BPH (Enlarged Prostate)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00029822
First received: January 23, 2002
Last updated: June 6, 2008
Last verified: June 2008

January 23, 2002
June 6, 2008
May 2001
Not Provided
occurrence of first episode of acute urinary retention (AUR)
Not Provided
Complete list of historical versions of study NCT00029822 on ClinicalTrials.gov Archive Site
need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Urinary Retention
  • Prostatic Hyperplasia
  • Benign Prostatic Hypertrophy
Drug: Alfuzosin (SL770499)
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1522
March 2005
Not Provided
  • 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
Male
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Bulgaria,   Canada,   Denmark,   Finland,   Greece,   Hungary,   Israel,   Netherlands,   Norway,   Poland,   Portugal,   Romania,   South Africa,   Spain,   Sweden
 
NCT00029822
EFC4485, SL770499
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
June 2008

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