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

Information source: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Benign Prostate Hyperplasia

Intervention: Tamsulosin (Drug); Tamsulosin (Drug); Tamsulosin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hanmi Pharmaceutical Company Limited

Official(s) and/or principal investigator(s):
Lee, MD, Principal Investigator, Affiliation: Hanyang University

Overall contact:
Mina Ham, CRA, Phone: 02-410-8742, Ext: 8742, Email: hammina@hanmi.co.kr

Summary

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

Clinical Details

Official 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

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

Primary outcome: Total International Prostate Symptom Score

Secondary outcome: Total International Prostate Symptom Score

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- Hypersensitivity to investigational products or components

- PSA>=4ng/ml

Locations and Contacts

Mina Ham, CRA, Phone: 02-410-8742, Ext: 8742, Email: hammina@hanmi.co.kr

Hanyang University Guri Hospital, Seoul, Korea, Republic of; Recruiting
Lee, MD, Principal Investigator
Additional Information

Starting date: October 2014
Last updated: March 17, 2015

Page last updated: August 20, 2015

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