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CompletedNCT00280605Updated Aug 31, 2010

ALF-ONE : ALFuzosin ONcE Daily

A Phase 4 interventional study of Alfuzosin in Prostatic Hyperplasia, sponsored by Sanofi. Completed. Open to male participants. Per ClinicalTrials.gov, last updated 2010-08-31.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Sex
Male
01

Study 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).

02

Conditions studied

  • Prostatic Hyperplasia
03

In context

Prostatic Hyperplasia

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

This study's enrollment of 200 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

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

Interventions

  • DrugAlfuzosin
06

What researchers measure

Primary outcomes

  1. Spontaneous adverse events

  2. Blood pressure and heart rate measured in sitting position

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

  4. DAN-PSS sexual function score

  5. PSA levels measured at baseline

  6. Maximum flow rate and residual urine

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00280605
Lead sponsor
Sanofi
First posted
Jan 23, 2006
Start date
Aug 2005
Primary completion
Feb 2006
Completion
Feb 2006
Last update
Aug 31, 2010

Study contacts

Benedict Blayney, MD
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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