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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00399464

Collaborator

(none)

1,177

Enrollment

Location

Duration (Months)

107.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Drug: alfuzosin	Phase 3

Study Design

Study Type:

Interventional

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 :

Nov 1, 2006

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts 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;