Overview

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

Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
0
Participant gender:
Male
Summary
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Alfuzosin
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.