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
1 other identifier
interventional
494
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 23, 2015
CompletedFirst Posted
Study publicly available on registry
March 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedOctober 13, 2016
October 1, 2016
7 months
February 23, 2015
October 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Total International Prostate Symptom Score
12 weeks
Secondary Outcomes (1)
Total International Prostate Symptom Score
4, 8 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORTamsulosin placebo (12 weeks)
Treatment 1
EXPERIMENTALHGP0412 capsule (12 weeks)
Treatment2
EXPERIMENTALHIP1402 capsule (12 weeks)
Interventions
Eligibility Criteria
You may qualify if:
- age\>=45, male, diagnosed on BPH, Total IPSS\>=13
You may not qualify if:
- Hypersensitivity to investigational products or components
- PSA\>=4ng/ml
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanyang University Guri Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 29490509DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lee, MD
Hanyang University Guri Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2015
First Posted
March 18, 2015
Study Start
October 1, 2014
Primary Completion
May 1, 2015
Study Completion
July 1, 2015
Last Updated
October 13, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share