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

A Multicenter, Randomized, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With Benign Prostatic Hyperplasia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02390882

Enrollment

494

Registered

2015-03-18

Start date

2014-10-31

Completion date

2015-07-31

Last updated

2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostate Hyperplasia

Brief summary

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

Detailed description

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

Interventions

DRUGPlacebo

Placebo

DRUGHGP0412 capsule

Tamsulon high dose

DRUGHIP1402 capsule

Tamsulon high dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* age\>=45, male, diagnosed on BPH, Total IPSS\>=13

Exclusion criteria

* Hypersensitivity to investigational products or components * PSA\>=4ng/ml

Design outcomes

Primary

Measure	Time frame
Total International Prostate Symptom Score	12 weeks

Secondary

Measure	Time frame
Total International Prostate Symptom Score	4, 8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026