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

Primary Purpose

Prostatic Diseases

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Alfuzosin
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

improvements in urinary symptoms and quality of life index

Secondary Outcome Measures

Improvement in sexual function
Improvement in maximum flow rate (determined by uroflowmetry)
Collection of spontaneously reported adverse events

Full Information

First Posted
December 17, 2007
Last Updated
April 8, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00575913
Brief Title
Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study
Acronym
ALEX-XL
Official Title
ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Other Intervention Name(s)
(Xatral XL)
Intervention Description
Alfuzosin 10 mg One tablet per day after evening meal
Primary Outcome Measure Information:
Title
improvements in urinary symptoms and quality of life index
Time Frame
During all the study conduct
Secondary Outcome Measure Information:
Title
Improvement in sexual function
Time Frame
During all the study conduct
Title
Improvement in maximum flow rate (determined by uroflowmetry)
Time Frame
During all the study conduct
Title
Collection of spontaneously reported adverse events
Time Frame
At each visit

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paibulsirijit Sompob
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

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Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study

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