Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With 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. Identifier: NCT00399464
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : October 2, 2009
Information provided by:

Brief Summary:

The primary objective of the study is to demonstrate the superiority of SL77.0499-10 10mg once daily over placebo and the non-inferiority versus tamsulosin hydrochloride after 12 weeks treatment in terms of the efficacy in patients with lower urinary tract symptoms related to BPH.

The secondary objective is to assess the safety of SL77.0499-10 in patients with lower urinary tract symptoms related to BPH in comparison with placebo and tamsulosin hydrochloride.

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Drug: alfuzosin Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of SL77.0499-10 10mg Once Daily in Comparison With Placebo and Tamsulosin Hydrochloride 0.2mg in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).
Study Start Date : November 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in I-PSS (International Prostate Symptom Score) total score from baseline to endpoint (Day 84 or last available post-baseline assessment)

Secondary Outcome Measures :
  1. Efficacy: Change in I-PSS total score from baseline to each visit
  2. Change in Quality Of Life score from baseline to each visit
  3. Change from baseline to endpoint of residual urine volume and urinary Peak Flow
  4. Safety:Adverse events

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Japanese;
  • Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography within the last 6 months;
  • Suffering for at least 6 months from lower urinary tract symptoms related to BPH.

Exclusion Criteria:

  • Patients with mental disorders or who cannot be relied upon to understand the trial requirements and comply with the treatment regiment;
  • Inpatient;
  • Patients having participated in a clinical trial within the previous 6-month;
  • Patients previously treated with SL77.0499-10;
  • Patients whose I-PSS total score do not meet ≥ 13;
  • Patients whose urinary peak flow rate (PFR) do not meet 5.0-12.0mL/s for a voided volume of at least 150mL;
  • Patients whose residual urine are > 200mL;

The investigator will evaluate whether there are other reasons why a patient may not participate.

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 identifier (NCT number): NCT00399464

Layout table for location information
Tokyo, Japan
Sponsors and Collaborators
Layout table for investigator information
Study Director: ICD CSD Sanofi
Layout table for additonal information
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00399464    
Other Study ID Numbers: EFC5791
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: October 2, 2009
Last Verified: October 2009
Keywords provided by Sanofi:
Benign Prostatic Hyperplasia
Adrenergic alpha-Antagonists
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
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