Official Title: “Evaluation of the Effect of 10 mg Alfuzosin (Alfetim Uno®) o. d. in Patients Presenting Low-Urinary Tract Symptoms”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Alfuzosin

Primary Measures

• 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)
  • Time Frame: 6 months
    

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Laszlo Eros Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00637715

Study ID Number: L_8758

ClinicalTrials.gov Identifier: NCT00637715

Health Authority: Hungary: OGYI (Országos Gyógyszerészeti Intézet)

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