Once Daily Given Alfuzosin in the Treatment of BPH - Tabular View

Tracking Information

First Received Date ^ICMJE

March 11, 2008

Last Updated Date

April 1, 2008

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00637715 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Once Daily Given Alfuzosin in the Treatment of BPH

Official Title ^ICMJE

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Benign Prostatic Hyperplasia

Intervention ^ICMJE

Drug: Alfuzosin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Male

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Hungary

Administrative Information

NCT ID ^ICMJE

NCT00637715

Responsible Party

Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

L_8758

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Laszlo Eros

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP