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)...
Date First Received: January 20, 2006
Last Updated: January 24, 2008
Verified by: Sanofi-Aventis, January 2008
Clinical Trial Phase: Phase 4 | Start Date: August 2005
Overall Status: Completed
Estimated Enrollment: 200
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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).
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Alfuzosin
Outcome Measures for this Clinical Trial
Primary 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Sanofi-Aventis
Overall Clinical Trial Officials and Contacts
Benedict Blayney, MD Study Director Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00280605
Study ID Number: PM_L_0168
ClinicalTrials.gov Identifier: NCT00280605
Health Authority: China: State Food and Drug Administration
Clinical Trials Authorship and Review
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