Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00575913

Purpose

To assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (Xatral XL) in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).

Condition	Intervention	Phase
Prostatic Diseases	Drug: Alfuzosin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study

Resource links provided by NLM:

MedlinePlus related topics: Prostate Diseases

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

improvements in urinary symptoms and quality of life index [ Time Frame: During all the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement in sexual function [ Time Frame: During all the study conduct ] [ Designated as safety issue: No ]
Improvement in maximum flow rate (determined by uroflowmetry) [ Time Frame: During all the study conduct ] [ Designated as safety issue: No ]
Collection of spontaneously reported adverse events [ Time Frame: At each visit ] [ Designated as safety issue: Yes ]

Enrollment:	118
Study Start Date:	September 2003
Study Completion Date:	March 2005

Intervention Details:

Alfuzosin 10 mg One tablet per day after evening meal

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ambulatory patients suffering from lower urinary tract symptoms suggestive of BPH.

Exclusion Criteria:

Patients requiring BPH surgery immediately or within the 12 following months:
- Acute renal obstruction
- Chronic renal obstruction
- Chronic renal failure from BPH
- Bladder stone
- Recurrent urinary tract infection
- Other bladder pathology such as cancer of the bladder, bladder bidiverticulum (big size)
- Hematuria from BPH
Patients whose urinary symptoms are satisfactorily controlled on other BPH medication ( alpha-blockers or 5 alpha-reductase)
Patients previously not improved by an alpha1-blocker treatment
Known hypersensitivity to alfuzosin
History of postural hypotension or syncope
Combination with other alpha1-blockers
Hepatic enzyme (SGOT or/and SGPT ) > 1.5 Upper Normal Limit
Unstable angina pectoris
Severe concomitant condition threatening life.
Patients who had failed treatment with finasteride (Proscar)
Patients with neuropathic bladder.
Patients with history of previous surgery for BPH
Patients with high risk for prostate cancer based on the clinical judgement of the investigator

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: NCT00575913

Locations

Thailand
Sanofi-aventis
Bangkok, Thailand

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Paibulsirijit Sompob

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	L_8935
Study First Received:	December 17, 2007
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00575913 History of Changes
Health Authority:	Thailand: Food and Drug Administration

Additional relevant MeSH terms:

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

Genital Diseases, Male
Antihypertensive Agents
Pharmacologic Actions
Alfuzosin
Therapeutic Uses
Adrenergic Antagonists

ClinicalTrials.gov processed this record on November 27, 2009