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

Condition(s) targeted: Prostatic Hyperplasia

Intervention: alfuzosin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Takashi TAKAGI, Study Director, Affiliation: Sanofi-Aventis

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.

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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

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

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

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.

Sanofi-Aventis, Tokyo, Japan

Starting date: November 2006
Last updated: January 18, 2008