The Efficacy, Onset of Effect, and Safety of Alfuzosin Once Daily in the Treatment of Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A Randomized, Placebo-Controlled Trial Using an Acute International Prostate Score
Completed · Phase 3
Conditions studied: Benign Prostatic Hyperplasia
In brief
Primary: Evaluate the safety and onset of symptom relief using an acute I-PSS form (7 day form). Determine onset of urinary peak flow improvement after 7 days Secondary: Determine improvement in Bother Score after 7 \& 28 days; improvement in sexual function after 28 days; assess one-month efficacy and safety
Key facts
- Study ID
- NCT00540891
- Run by
- Sanofi
- People needed
- 372
- Starts
- 2003-02-01
- Expected to finish
- 2004-10-01
- Last updated by the study team
- 2007-10-08
Who can join
Age: 50 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Men aged greater than or equal to 50 years with a history of lower urinary tract symptoms (LUTS) related to BPH for greater than or equal to 6 months, an International Prostate Symptom Score (I-PSS) (0 to 35 points scale) of at least 13 points, a maximum urinary flow rate (Qmax) between 5 and 12 mL/sec (with a voided volume of greater than or equal to 150 mL), a residual urine volume of less than or equal to 350 mL, and a bothersomeness score (0 to 6 points scale) of at least 3 points. All patients will undergo prostate size assessment by transrectal ultrasonography (TRUS) if not done within past 12 months.
You may not qualify if…
- Include, but are not limited to: concomitant lower urinary tract disease; previous prostatic surgery; history of postural hypotension or syncope; concomitant use of medications that may alter the voiding pattern; and clinically relevant biochemical abnormalities. Patients with a serum prostate-specific antigen (PSA) >10 ng/mL will be excluded, and those with an elevated serum PSA between 4 and 10 ng/mL must have prostate cancer excluded to the satisfaction of the investigator.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where it is running
- Sanofi-Aventis — Bridgewater, New Jersey, United States
Full record on ClinicalTrials.gov
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