Back to resultsA Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With BPH
Primary Purpose
Benign Prostate Hyperplasia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo
HGP0412 capsule
HIP1402 capsule
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostate Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- age>=45, male, diagnosed on BPH, Total IPSS>=13
Exclusion Criteria:
- Hypersensitivity to investigational products or components
- PSA>=4ng/ml
Sites / Locations
- Hanyang University Guri Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Treatment 1
Treatment2
Arm Description
Tamsulosin placebo (12 weeks)
HGP0412 capsule (12 weeks)
HIP1402 capsule (12 weeks)
Outcomes
Primary Outcome Measures
Total International Prostate Symptom Score
Secondary Outcome Measures
Total International Prostate Symptom Score
Full Information
NCT ID
NCT02390882
First Posted
February 23, 2015
Last Updated
October 12, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT02390882
Brief Title
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With BPH
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostate Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
494 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tamsulosin placebo (12 weeks)
Arm Title
Treatment 1
Arm Type
Experimental
Arm Description
HGP0412 capsule (12 weeks)
Arm Title
Treatment2
Arm Type
Experimental
Arm Description
HIP1402 capsule (12 weeks)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Tamsulosin Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
HGP0412 capsule
Other Intervention Name(s)
Tamsulosin HCl 0.2mg
Intervention Description
Tamsulon high dose
Intervention Type
Drug
Intervention Name(s)
HIP1402 capsule
Other Intervention Name(s)
Tamsulosin HCl 0.4mg
Intervention Description
Tamsulon high dose
Primary Outcome Measure Information:
Title
Total International Prostate Symptom Score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Total International Prostate Symptom Score
Time Frame
4, 8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age>=45, male, diagnosed on BPH, Total IPSS>=13
Exclusion Criteria:
Hypersensitivity to investigational products or components
PSA>=4ng/ml
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee, MD
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Guri Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29490509
Citation
Chung JH, Oh CY, Kim JH, Ha US, Kim TH, Lee SH, Han JH, Bae JH, Chang IH, Han DH, Yoo TK, Chung JI, Kim SW, Jung J, Kim YI, Lee SW. Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms: a randomized, double-blind, phase 3 trial. Curr Med Res Opin. 2018 Oct;34(10):1793-1801. doi: 10.1080/03007995.2018.1447451. Epub 2018 Apr 12.
Results Reference
derived
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A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With BPH
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