Once Daily Given Alfuzosin in the Treatment of BPH
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: Alfuzosin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Laszlo Eros, Study Director, Affiliation: Sanofi-Aventis
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
Clinical Details
Official title: Evaluation of the Effect of 10 mg Alfuzosin (Alfetim Uno®) o. d. in Patients Presenting Low-Urinary Tract Symptoms
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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)
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Male.
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.
Locations and Contacts
Sanofi-Aventis, Budapest, Hungary
Additional Information
clinicalstudyresults.org
Starting date: October 2003
Ending date: December 2004
Last updated: April 1, 2008
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