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ALF-ONE : ALFuzosin ONcE Daily

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ClinicalTrials.gov Identifier: NCT00280605
Recruitment Status : Completed
First Posted : January 23, 2006
Last Update Posted : August 31, 2010
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Drug: Alfuzosin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280605


Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Benedict Blayney, MD Sanofi
More Information
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ClinicalTrials.gov Identifier: NCT00280605     History of Changes
Other Study ID Numbers: PM_L_0168
First Posted: January 23, 2006    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
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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