NCT00637715

Brief Summary

Collection of the data on the safety and efficacy of the once daily administration of the alfuzosin preparation /Alfetim Uno® l0 mg/ at patients with lower urinary tract symptoms/complaints rendering possible the presence of benign prostatic hyperplasia, in the course of everyday practice

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
Last Updated

April 3, 2008

Status Verified

April 1, 2008

First QC Date

March 11, 2008

Last Update Submit

April 1, 2008

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • To collect additional clinical data on the safety profile and efficacy of alfuzosin 10 mg o. d. in patients with low-urinary tract symptoms caused by benign prostatic hyperplasia (BPH)

    6 months

Interventions

AlfuzosinDRUG

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present

You may not qualify if:

  • Necessity of surgical intervention immediately or within 12 months because of BPH
  • The patient has earlier /within 6 months/ obtained treatment because of BPH
  • The patient did not improve on earlier alpha-1 blocker treatment
  • Known hypersensitivity to alfuzosin
  • Orthostatic hypotension in the history
  • Concomitant application with another alpha-1 blocker
  • Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/
  • Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/
  • Intestinal obstruction /because of the castor oil content of the drug/
  • Tumorous disease
  • Severe, life threatening state
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Budapest, Hungary

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Laszlo Eros

    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

March 11, 2008

First Posted

March 18, 2008

Study Start

October 1, 2003

Study Completion

December 1, 2004

Last Updated

April 3, 2008

Record last verified: 2008-04

Locations

HU(1)