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ALF-ONE : ALFuzosin ONcE Daily

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00280605
First received: January 20, 2006
Last updated: August 30, 2010
Last verified: August 2010
History of Changes
  Purpose
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:

U.S. FDA Resources

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)
  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280605

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

ClinicalTrials.gov 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:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Alfuzosin
Adrenergic alpha-1 Receptor Antagonists
 Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents

ClinicalTrials.gov processed this record on September 23, 2016