Once Daily Given Alfuzosin in the Treatment of BPH

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: Male

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 possible the presence of benign prostatic hyperplasia, in the course of everyday practice

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Alfuzosin

Criteria

Inclusion Criteria:

• Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present

Exclusion Criteria:

• 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.