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).”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: alfuzosin

Primary Measures

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

Secondary 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

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Takashi TAKAGI Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00399464

Study ID Number: EFC5791

ClinicalTrials.gov Identifier: NCT00399464

Health Authority: Japan: Ministry of Health, Labor and Welfare