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
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