NCT01260129

Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH

Safety and Efficacy of 8mg Once-daily Versus 4mg Twice-daily Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH ; 12-week, Double-blind, Randomized, Comparison, Multi-center Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety.

Detailed description

Silodosin is a highly selective α1A-adrenoceptor antagonist for the treatment of the signs and symptoms of BPH. 4mg Silodosin twice daily has been approved in Asia including Japan and Korea. In US, 8mg Silodosin once daily with the FDA approval is already available. Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety. The study used double-blind, random assignment in Korean men with signs and symptoms of BPH for 12 weeks.

Conditions

• Benign Prostatic Hypertrophy

Interventions

Type	Name	Description
DRUG	Silodosin	Silodosin 8 mg orally, once daily after morning meal
DRUG	Silodosin	Silodosin 4 mg orally, twice daily after morning and evening meal

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-11-01
• Completion: 2011-10-01
• First posted: 2010-12-15
• Last updated: 2012-03-30

Locations

14 sites across 1 country: South Korea