Status:
COMPLETED
ALF-ONE : ALFuzosin ONcE Daily
Lead Sponsor:
Sanofi
Conditions:
Prostatic Hyperplasia
Eligibility:
MALE
Phase:
PHASE4
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 low...
Eligibility Criteria
Inclusion
- Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00280605
Start Date
August 1 2005
End Date
February 1 2006
Last Update
August 31 2010
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