ALF-ACUTE: 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
Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00540891
Collaborator
(none)
372
1
20
18.6
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
372 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date
:
Feb 1, 2003
Actual Study Completion Date
:
Oct 1, 2004
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis | Bridgewater | New Jersey | United States | 08807 |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Yasir Nagarwala, M.D., Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00540891
Other Study ID Numbers:
- L_8472
First Posted:
Oct 8, 2007
Last Update Posted:
Oct 8, 2007
Last Verified:
Oct 1, 2007
Additional relevant MeSH terms: