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

NCT00540891 | Completed Phase 3

• 1 other identifier: L_8472
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

• Evaluate the safety and onset of symptom relief using an acute I-PSS form(7 day form).

  7 day

• Determine onset of urinary peak flow improvement

  after 7 days

Secondary Outcomes (3)

• Determine improvement in Bother Score

  after 7 & 28 days

• To determine the improvement in sexual function

  after 28 days

• Assess one-month efficacy and safety

  one month

Interventions

ALFUZOSIN DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yasir Nagarwala, M.D.

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 8, 2007
• Study Start: February 1, 2003
• Study Completion: October 1, 2004
• Last Updated: October 8, 2007

Record last verified: 2007-10

Locations

US (1)