Once Daily Given Alfuzosin in the Treatment of BPH

This study has been completed.

First Received: March 11, 2008 Last Updated: April 1, 2008 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00637715

Purpose

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

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: Alfuzosin	Phase IV

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Effect of 10 mg Alfuzosin (Alfetim Uno®) o. d. in Patients Presenting Low-Urinary Tract Symptoms

Further study details as provided by Sanofi-Aventis:

Primary Outcome 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 ]

Enrollment:	60
Study Start Date:	October 2003
Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637715

Locations

Hungary
Sanofi-Aventis
Budapest, Hungary

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Laszlo Eros

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Study Director )
Study ID Numbers:	L_8758
Study First Received:	March 11, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00637715 History of Changes
Health Authority:	Hungary: OGYI (Országos Gyógyszerészeti Intézet)

Study placed in the following topic categories:

Neurotransmitter Agents
Hyperplasia
Alfuzosin
Adrenergic Agents
Prostatic Diseases
Prostatic Hyperplasia

Adrenergic Antagonists
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Genital Diseases, Male

Additional relevant MeSH terms:

Neurotransmitter Agents
Prostatic Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents

Genital Diseases, Male
Pharmacologic Actions
Hyperplasia
Pathologic Processes
Alfuzosin
Prostatic Hyperplasia
Therapeutic Uses
Adrenergic Antagonists

ClinicalTrials.gov processed this record on May 07, 2009