NCT00399464

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

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).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,177 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	alfuzosin

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-11-14
• Last updated: 2009-10-02

Locations

1 site across 1 country: Japan