NCT01922375

Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Design Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 411 (actual)
• Sponsor: Dong-A Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of Naftopidil in Korean male patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia. The investigators hypothesized that Naftopidil which came onto marcket in Japan would effect in improvement of voiding and storage difficulty. Design: Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design

Conditions

• Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Naftopidil

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2013-08-14
• Last updated: 2013-08-14

Locations

1 site across 1 country: South Korea