Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
Phase 4
Completed
- Conditions
- Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
- Interventions
- Registration Number
- NCT01922375
- Lead Sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 411
Inclusion Criteria
- Male patients aged 4 years or more diagnosed with BPH
Exclusion Criteria
- subjects with uncontrolled blood pressure
- subjects with hepatic or renal dysfunction
- subjects with prostate cancer
- Had treatments for BPH using other alpha receptor antagonists within 2 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Naftopidil dose 2 Naftopidil PO administration Naftopidil dose 1 Naftopidil PO administration
- Primary Outcome Measures
Name Time Method Efficacy(IPSS score change) From 0 week(baseline) to 12 week(end of the treatment)
- Secondary Outcome Measures
Name Time Method Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ) From 0 week(baseline) to 12 week(end of the treatment)
Trial Locations
- Locations (1)
Chonnam national university hospital
🇰🇷Gwangju, Korea, Republic of