NCT00280605

Brief Summary

The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_4

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

August 31, 2010

Status Verified

August 1, 2010

Enrollment Period

6 months

First QC Date

January 20, 2006

Last Update Submit

August 30, 2010

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (6)

  • Spontaneous adverse events

  • Blood pressure and heart rate measured in sitting position

  • International Prostate Symptom Score (IPSS) and quality of life index

  • DAN-PSS sexual function score

  • PSA levels measured at baseline

  • Maximum flow rate and residual urine

Interventions

AlfuzosinDRUG

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia

You may not qualify if:

  • Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months
  • Patients previously not improved by an alpha 1-blocker treatment
  • Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI)
  • Known hypersensitivity to alfuzosin
  • History of postural hypotension or syncope
  • Combination with other alpha 1-blockers
  • Hepatic insufficiency
  • Unstable angina pectoris
  • Severe concomitant condition threatening life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Benedict Blayney, MD

    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

January 20, 2006

First Posted

January 23, 2006

Study Start

August 1, 2005

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

August 31, 2010

Record last verified: 2010-08