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Completed

NCT Number: NCT02390882

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

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

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Key information

Conditions

Benign Prostate Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Hanyang University Guri Hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Placebo

Drug

Placebo

Other names: Tamsulosin Placebo

HGP0412 capsule

Drug

Tamsulon high dose

Other names: Tamsulosin HCl 0.2mg

HIP1402 capsule

Drug

Tamsulon high dose

Other names: Tamsulosin HCl 0.4mg

Primary outcomes

  1. Total International Prostate Symptom Score

    Time frame: 12 weeks

Secondary outcomes

  1. Total International Prostate Symptom Score

    Time frame: 4, 8 weeks

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2015
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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