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

Tracking Information

First Received Date ^ICMJE

December 17, 2007

Last Updated Date

April 8, 2008

Start Date ^ICMJE

September 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00575913 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study

Official Title ^ICMJE

ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study

Brief Summary

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).

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

Prostatic Diseases

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

118

Completion Date

March 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT ID ^ICMJE

NCT00575913

Responsible Party

Study ID Numbers ^ICMJE

L_8935

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Paibulsirijit Sompob

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