Once Daily Given Alfuzosin in the Treatment of BPH

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00637715

First received: March 11, 2008

Last updated: April 1, 2008

Last verified: April 2008

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of the Effect of 10 mg Alfuzosin (Alfetim Uno®) o. d. in Patients Presenting Low-Urinary Tract Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Enlarged Prostate (BPH)

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Further study details as provided by Sanofi:

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 (Adult, Senior)
Sexes 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Hungary
Sanofi-Aventis
Budapest, Hungary

Sponsors and Collaborators

Sanofi

Investigators


Study Director:	Laszlo Eros	Sanofi

More Information


Responsible Party:	Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00637715 History of Changes
Other Study ID Numbers:	L_8758
Study First Received:	March 11, 2008
Last Updated:	April 1, 2008

Additional relevant MeSH terms:


Hyperplasia Prostatic Hyperplasia Pathologic Processes Prostatic Diseases Genital Diseases, Male Alfuzosin Adrenergic alpha-1 Receptor Antagonists	Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents

ClinicalTrials.gov processed this record on June 23, 2017

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