ALF-ONE : ALFuzosin ONcE Daily

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: January 20, 2006
Last updated: August 30, 2010
Last verified: August 2010

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).

Condition Intervention Phase
Prostatic Hyperplasia
Drug: Alfuzosin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Outcome of Patients With Lower Urinary Symptoms Suggestive of Benign Prostatic Hyperplasia and Treated With Alfuzosin 10 mg Once Daily for 3 Months in China

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: August 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00280605

Sponsors and Collaborators
Study Director: Benedict Blayney, MD Sanofi
  More Information

No publications provided Identifier: NCT00280605     History of Changes
Other Study ID Numbers: PM_L_0168
Study First Received: January 20, 2006
Last Updated: August 30, 2010
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 17, 2014