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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01922375

Enrollment

411

Registered

2013-08-14

Start date

2011-12-31

Completion date

2012-09-30

Last updated

2013-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

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

Interventions

DRUGNaftopidil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Efficacy(IPSS score change)	From 0 week(baseline) to 12 week(end of the treatment)

Secondary

Measure	Time frame
Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ)	From 0 week(baseline) to 12 week(end of the treatment)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026