Clinical trial NCT01922375: Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 411
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy(IPSS score change)
timeFrame: From 0 week(baseline) to 12 week(end of the treatment)
Secondary outcomes:
measure: Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ)
timeFrame: From 0 week(baseline) to 12 week(end of the treatment)
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam national university hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Sae-Woong Kim, MD.PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gyeongsang National University Hospital
name: Jae-Seok Hyun, Md, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Guro Hospital
name: Du-Geon Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: Nam-Cheol Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Sung-Won Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Soo-Woong Kim, Md, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Tai-Young Ahn, Md, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeongnam University Hospital
name: Ki-Hak Moon, Md, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University Hospital
name: Woo-Sik Chung, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Kweon-Sik Min, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Jong Kwan Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangdong Sacred Heart Hospital
name: Dae Yul Yang Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Ji- Kan Ryu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: