Once Daily Given Alfuzosin in the Treatment of BPH

Sanofi

Status and phase: Completed; Phase 4

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Alfuzosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00637715

L_8758

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)