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Dose Ranging Study of Alfuzosin in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00409357
Recruitment Status : Completed
First Posted : December 8, 2006
Last Update Posted : October 2, 2009
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:

The primary objective is to assess the dose-response relationship of SL77.0499 10 (alfuzosin hydrochloride) 5 mg, 10 mg, 15 mg, and placebo once daily during a 12-week oral administration period for the efficacy in patients with lower urinary tract symptoms (LUTS) related to BPH.

Secondary objectives are to assess the efficacy of each dose of alfuzosin as compared with placebo and to assess the safety of each dose of alfuzosin.


Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: SL77.0499-10 (alfuzosin hydrochloride) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 473 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of SL77.0499-10 Once Daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH)
Study Start Date : November 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The primary efficacy assessment is the change from baseline in International Prostate Symptom Score (IPSS) total score at the end-of-study (EOS) visit.

Secondary Outcome Measures :
  1. Efficacy: changes from baseline in IPSS total score by visit;·IPSS irritative and obstructive subscores,·urinary peak flow rate and residual urine volume at EOS and by visit.
  2. Safety: adverse events, vital signs, laboratory tests.

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • suffering from LUTS related to BPH for at least 6 months;
  • having an IPSS >13;
  • having a urinary peak flow rate 5.0 to 12.0 mL/s for a voided volume of at least 150 mL;
  • having a residual urine volume < or = 200 mL.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00409357


Locations
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Japan
Sanofi-Aventis
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: ICD CSD Sanofi
More Information
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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00409357    
Other Study ID Numbers: DRI5234
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: October 2, 2009
Last Verified: October 2009
Keywords provided by Sanofi:
urinary tract
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Urological Manifestations
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