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

April 8, 2008 updated by: Sanofi

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
improvements in urinary symptoms and quality of life index
Time Frame: During all the study conduct
During all the study conduct

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in sexual function
Time Frame: During all the study conduct
During all the study conduct
Improvement in maximum flow rate (determined by uroflowmetry)
Time Frame: During all the study conduct
During all the study conduct
Collection of spontaneously reported adverse events
Time Frame: At each visit
At each visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Paibulsirijit Sompob, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

April 10, 2008

Last Update Submitted That Met QC Criteria

April 8, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_8935

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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