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Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia

Primary Purpose

Prostatic Hyperplasia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
alfuzosin
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, Adrenergic alpha-Antagonists, alfuzosin

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

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

Efficacy: Change in I-PSS total score from baseline to each visit
Change in Quality Of Life score from baseline to each visit
Change from baseline to endpoint of residual urine volume and urinary Peak Flow
Safety:Adverse events

Full Information

First Posted
November 13, 2006
Last Updated
October 1, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00399464
Brief Title
Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia
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 Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia
Keywords
Benign Prostatic Hyperplasia, Adrenergic alpha-Antagonists, alfuzosin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1177 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
alfuzosin
Primary Outcome Measure Information:
Title
Change in I-PSS (International Prostate Symptom Score) total score from baseline to endpoint (Day 84 or last available post-baseline assessment)
Secondary Outcome Measure Information:
Title
Efficacy: Change in I-PSS total score from baseline to each visit
Title
Change in Quality Of Life score from baseline to each visit
Title
Change from baseline to endpoint of residual urine volume and urinary Peak Flow
Title
Safety:Adverse events

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia

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