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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| ClinicalTrials.gov Identifier: NCT00540891 |
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Recruitment Status :
Completed
First Posted : October 8, 2007
Last Update Posted : October 8, 2007
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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 |
|---|---|---|
| Benign Prostatic Hyperplasia | Drug: ALFUZOSIN | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| 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 : | February 2003 |
| Actual Study Completion Date : | October 2004 |
- 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 ]
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540891
| United States, New Jersey | |
| Sanofi-Aventis | |
| Bridgewater, New Jersey, United States, 08807 | |
| Study Director: | Yasir Nagarwala, M.D. | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00540891 History of Changes |
| Other Study ID Numbers: |
L_8472 |
| First Posted: | October 8, 2007 Key Record Dates |
| Last Update Posted: | October 8, 2007 |
| Last Verified: | October 2007 |
Additional relevant MeSH terms:
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Prostatic Hyperplasia 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 |