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

NCT01922375 | Completed Phase 4

• 1 other identifier: FLV_BPH_IV-1
• Study Type: interventional
• Target: 411
• Locations: 1 country
• Sites: 1

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

Conditions

Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Efficacy(IPSS score change)

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

Secondary Outcomes (1)

• Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ)

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

Study Arms (3)

Naftopidil dose 2

EXPERIMENTAL

PO administration

Drug: Naftopidil

Placebo

PLACEBO COMPARATOR

PO administration

Naftopidil dose 1

EXPERIMENTAL

PO administration

Drug: Naftopidil

Interventions

Naftopidil DRUG

Naftopidil dose 1; Naftopidil dose 2

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged 4 years or more diagnosed with BPH

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chonnam national university hospital

Gwangju, South Korea

Location

MeSH Terms

Interventions

naftopidil

Study Officials

• Sae-Woong Kim, MD.PhD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Jae-Seok Hyun, Md, PhD

  Gyeongsang National University Hospital

  PRINCIPAL INVESTIGATOR

• Du-Geon Moon, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Nam-Cheol Park, MD, PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

• Sung-Won Lee, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Soo-Woong Kim, Md, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Tai-Young Ahn, Md, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Ki-Hak Moon, Md, PhD

  Yeongnam University Hospital

  PRINCIPAL INVESTIGATOR

• Woo-Sik Chung, MD,PhD

  Ewha Womans University Hospital

  PRINCIPAL INVESTIGATOR

• Kweon-Sik Min, MD, PhD

  Inje University

  PRINCIPAL INVESTIGATOR

• Jong Kwan Park, MD, PhD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

• Dae Yul Yang Yang, MD, PhD

  Kangdong Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

• Ji- Kan Ryu, MD, PhD

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: August 14, 2013
• Study Start: December 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 14, 2013

Record last verified: 2013-08

Locations

KR (1)