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

NCT01922375 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2013-08-14

No results posted yet for this study

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

DRUG

Naftopidil

Sponsors & Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Sae-Woong Kim, MD.PhD · Seoul St. Mary's Hospital

  • Jae-Seok Hyun, Md, PhD · Gyeongsang National University Hospital

  • Du-Geon Moon, MD, PhD · Korea University Guro Hospital

  • Nam-Cheol Park, MD, PhD · Pusan National University Hospital

  • Sung-Won Lee, MD, PhD · Samsung Medical Center

  • Soo-Woong Kim, Md, PhD · Seoul National University Hospital

  • Tai-Young Ahn, Md, PhD · Asan Medical Center

  • Ki-Hak Moon, Md, PhD · Yeongnam University Hospital

  • Woo-Sik Chung, MD,PhD · Ewha Womans University Hospital

  • Kweon-Sik Min, MD, PhD · Inje University

  • Jong Kwan Park, MD, PhD · Chonbuk National University Hospital

  • Dae Yul Yang Yang, MD, PhD · Kangdong Sacred Heart Hospital

  • Ji- Kan Ryu, MD, PhD · Inha University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01922375 on ClinicalTrials.gov