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OpenTrials
Completed

NCT Number: NCT01922375

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

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

Completed

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Key information

Conditions

Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Chonnam national university hospital

Gwangju, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naftopidil

Drug

Primary outcomes

  1. Efficacy(IPSS score change)

    Time frame: From 0 week(baseline) to 12 week(end of the treatment)

Secondary outcomes

  1. Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ)

    Time frame: From 0 week(baseline) to 12 week(end of the treatment)

Sponsors and collaborators

Lead sponsor

Dong-A Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 14, 2013
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.