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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

D

Dong-A Pharmaceutical

Status and phase

Completed
Phase 4

Conditions

Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Treatments

Drug: Naftopidil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01922375
FLV_BPH_IV-1

Details and patient eligibility

About

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

Enrollment

411 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

411 participants in 3 patient groups, including a placebo group

Naftopidil dose 2
Experimental group
Description:
PO administration
Treatment:
Drug: Naftopidil
Placebo
Placebo Comparator group
Description:
PO administration
Naftopidil dose 1
Experimental group
Description:
PO administration
Treatment:
Drug: Naftopidil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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