Back to resultsALF-ONE : ALFuzosin ONcE Daily
Primary Purpose
Prostatic Hyperplasia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Alfuzosin
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria: Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia Exclusion Criteria: Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months Patients previously not improved by an alpha 1-blocker treatment Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI) Known hypersensitivity to alfuzosin History of postural hypotension or syncope Combination with other alpha 1-blockers Hepatic insufficiency Unstable angina pectoris Severe concomitant condition threatening life
Sites / Locations
Outcomes
Primary Outcome Measures
Spontaneous adverse events
Blood pressure and heart rate measured in sitting position
International Prostate Symptom Score (IPSS) and quality of life index
DAN-PSS sexual function score
PSA levels measured at baseline
Maximum flow rate and residual urine
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00280605
Brief Title
ALF-ONE : ALFuzosin ONcE Daily
Official Title
Study of the Outcome of Patients With Lower Urinary Symptoms Suggestive of Benign Prostatic Hyperplasia and Treated With Alfuzosin 10 mg Once Daily for 3 Months in China
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Primary Outcome Measure Information:
Title
Spontaneous adverse events
Title
Blood pressure and heart rate measured in sitting position
Title
International Prostate Symptom Score (IPSS) and quality of life index
Title
DAN-PSS sexual function score
Title
PSA levels measured at baseline
Title
Maximum flow rate and residual urine
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia
Exclusion Criteria:
Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months
Patients previously not improved by an alpha 1-blocker treatment
Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI)
Known hypersensitivity to alfuzosin
History of postural hypotension or syncope
Combination with other alpha 1-blockers
Hepatic insufficiency
Unstable angina pectoris
Severe concomitant condition threatening life
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedict Blayney, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
ALF-ONE : ALFuzosin ONcE Daily
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