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CompletedNCT00637715Updated Apr 3, 2008

Once Daily Given Alfuzosin in the Treatment of BPH

A Phase 4 interventional study of Alfuzosin in Benign Prostatic Hyperplasia, sponsored by Sanofi. Completed at 1 site in Hungary. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2008-04-03.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
40 Years and older
Sex
Male
01

Study 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

02

Conditions studied

  • Benign Prostatic Hyperplasia

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03

In context

Prostatic Hyperplasia

803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 60 is below the median of 96 across 610 interventional studies indexed under Prostatic Hyperplasia.

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Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

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04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Interventions

06

What researchers measure

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)

    Time frame: 6 months

07

Study locations

1 site
  • Sanofi-Aventis
    Budapest, Hungary
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00637715
Lead sponsor
Sanofi
First posted
Mar 18, 2008
Start date
Oct 2003
Completion
Dec 2004
Last update
Apr 3, 2008

Study contacts

Laszlo Eros
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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