Once Daily Given Alfuzosin in the Treatment of BPH

Verified by: Sanofi-Aventis, April 2008
First Received: March 11, 2008 | Last Updated: April 1, 2008 | Phase: Phase 4 | Start Date: October 2003
Overall Status: Completed | Estimated Enrollment: 60
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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...

Brief Summary

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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: Alfuzosin

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

Laszlo Eros Study Director Sanofi-Aventis  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00637715