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)
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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 |
- 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 ]
- 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 (Adult, Senior) |
| Genders 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00540891
| United States, New Jersey | |
| Sanofi-Aventis | |
| Bridgewater, New Jersey, United States, 08807 | |
| Study Director: | Yasir Nagarwala, M.D. | Sanofi |
More Information
| 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:
|
Hyperplasia Prostatic Hyperplasia Lower Urinary Tract Symptoms Pathologic Processes Prostatic Diseases Genital Diseases, Male Urological Manifestations Signs and Symptoms Alfuzosin |
Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |
ClinicalTrials.gov processed this record on September 29, 2016