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

Benign Prostatic Hyperplasia Clinical Trial

— ALF-ACUTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540891
• Other study ID #: L_8472
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2007
• Last updated: October 4, 2007
• Start date: February 2003
• Est. completion date: October 2004

Study information

• Verified date: October 2007
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• ALFUZOSIN

Locations

Country	Name	City	State
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety and onset of symptom relief using an acute I-PSS form(7 day form).		7 day
Primary	Determine onset of urinary peak flow improvement		after 7 days
Secondary	Determine improvement in Bother Score		after 7 & 28 days
Secondary	To determine the improvement in sexual function		after 28 days
Secondary	Assess one-month efficacy and safety		one month