NCT00575913

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
Last Updated

April 10, 2008

Status Verified

April 1, 2008

First QC Date

December 17, 2007

Last Update Submit

April 8, 2008

Conditions

Prostatic Diseases

Outcome Measures

Primary Outcomes (1)

  • improvements in urinary symptoms and quality of life index

    During all the study conduct

Secondary Outcomes (3)

  • Improvement in sexual function

    During all the study conduct

  • Improvement in maximum flow rate (determined by uroflowmetry)

    During all the study conduct

  • Collection of spontaneously reported adverse events

    At each visit

Interventions

AlfuzosinDRUG

Alfuzosin 10 mg One tablet per day after evening meal

Also known as: (Xatral XL)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Bangkok, Thailand

Location

MeSH Terms

Conditions

Prostatic Diseases

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Paibulsirijit Sompob

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 18, 2007

Study Start

September 1, 2003

Study Completion

March 1, 2005

Last Updated

April 10, 2008

Record last verified: 2008-04

Locations

TH(1)