Once Daily Given Alfuzosin in the Treatment of BPH
Phase 4
Completed
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- NCT00637715
- Lead Sponsor
- Sanofi
- 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 possible the presence of benign prostatic hyperplasia, in the course of everyday practice
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To collect additional clinical data on the safety profile and efficacy of alfuzosin 10 mg o. d. in patients with low-urinary tract symptoms caused by benign prostatic hyperplasia (BPH) 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-Aventis
🇭🇺Budapest, Hungary