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 (ALF-ACUTE)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00540891
First received: October 4, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: ALFUZOSIN
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Evaluate the safety and onset of symptom relief using an acute I-PSS form(7 day form). [ Time Frame: 7 day ]
  • Determine onset of urinary peak flow improvement [ Time Frame: after 7 days ]

Secondary Outcome Measures:
  • Determine improvement in Bother Score [ Time Frame: after 7 & 28 days ]
  • To determine the improvement in sexual function [ Time Frame: after 28 days ]
  • Assess one-month efficacy and safety [ Time Frame: one month ]

Enrollment: 372
Study Start Date: February 2003
Study Completion Date: October 2004
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540891

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Yasir Nagarwala, M.D. Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00540891     History of Changes
Other Study ID Numbers: L_8472
Study First Received: October 4, 2007
Last Updated: October 4, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Alfuzosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2014