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Once Daily Given Alfuzosin in the Treatment of BPH

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: Alfuzosin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Laszlo Eros, Study Director, Affiliation: Sanofi

Summary

Collection of the data on the safety and efficacy of the once daily administration of the alfuzosin preparation /Alfetim UnoŽ 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 UnoŽ) o. d. in Patients Presenting Low-Urinary Tract Symptoms

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

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

Starting date: October 2003
Last updated: April 1, 2008

Page last updated: August 23, 2015

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