A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With BPH

Hanmi Pharmaceutical Company Limited494 enrolled

Overview

The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with Benign Prostatic Hyperplasia

A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with benign prostatic hyperplasia

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

494

Conditions

Benign Prostate Hyperplasia

Interventions

PlaceboDRUG

Placebo

HGP0412 capsuleDRUG

Tamsulon high dose

HIP1402 capsuleDRUG

Tamsulon high dose

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age\>=45, male, diagnosed on BPH, Total IPSS\>=13 Exclusion Criteria: * Hypersensitivity to investigational products or components * PSA\>=4ng/ml

Locations (1)

Hanyang University Guri Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Total International Prostate Symptom Score

Time frame: 12 weeks

Secondary Outcomes

Total International Prostate Symptom Score

Time frame: 4, 8 weeks

Data from ClinicalTrials.gov

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