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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00575913
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : April 10, 2008
Sponsor:
Information provided by:
Sanofi

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).

Condition or disease Intervention/treatment Phase
Prostatic Diseases Drug: Alfuzosin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study
Study Start Date : September 2003
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Alfuzosin
    Alfuzosin 10 mg One tablet per day after evening meal
    Other Name: (Xatral XL)


Primary Outcome Measures :
  1. improvements in urinary symptoms and quality of life index [ Time Frame: During all the study conduct ]

Secondary Outcome Measures :
  1. Improvement in sexual function [ Time Frame: During all the study conduct ]
  2. Improvement in maximum flow rate (determined by uroflowmetry) [ Time Frame: During all the study conduct ]
  3. Collection of spontaneously reported adverse events [ Time Frame: At each visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575913


Locations
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Thailand
Sanofi-Aventis
Bangkok, Thailand
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Paibulsirijit Sompob Sanofi

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ClinicalTrials.gov Identifier: NCT00575913     History of Changes
Other Study ID Numbers: L_8935
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
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Prostatic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
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