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

Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922375
• Other study ID #: FLV_BPH_IV-1
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2013
• Last updated: August 11, 2013
• Start date: December 2011
• Est. completion date: September 2012

Study information

• Verified date: August 2013
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperplasia
• Lower Urinary Tract Symptoms
• Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Naftopidil

Locations

Country	Name	City	State
Korea, Republic of	Chonnam national university hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy(IPSS score change)		From 0 week(baseline) to 12 week(end of the treatment)	No
Secondary	Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ)		From 0 week(baseline) to 12 week(end of the treatment)	No