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

Phase 3

Completed

• Conditions: Prostatic Hyperplasia

• Registration Number: NCT00399464
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-13
• Study First Submitted QC: 2006-11-13
• Study First Posted: 2006-11-14
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-01
• Last Update Posted: 2009-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1177

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇯🇵 Tokyo, Japan