Status:
COMPLETED
Once Daily Given Alfuzosin in the Treatment of BPH
Lead Sponsor:
Sanofi
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
40+ years
Phase:
PHASE4
Brief Summary
Collection of the data on the safety and efficacy of the once daily administration of the alfuzosin preparation /Alfetim Uno® l0 mg/ at patients with lower urinary tract symptoms/complaints rendering ...
Eligibility Criteria
Inclusion
- Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present
Exclusion
- Necessity of surgical intervention immediately or within 12 months because of BPH
- The patient has earlier /within 6 months/ obtained treatment because of BPH
- The patient did not improve on earlier alpha-1 blocker treatment
- Known hypersensitivity to alfuzosin
- Orthostatic hypotension in the history
- Concomitant application with another alpha-1 blocker
- Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/
- Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/
- Intestinal obstruction /because of the castor oil content of the drug/
- Tumorous disease
- Severe, life threatening state
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00637715
Start Date
October 1 2003
End Date
December 1 2004
Last Update
April 3 2008
Active Locations (1)
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1
Sanofi-Aventis
Budapest, Hungary