Evaluating the Efficacy and Safety of HCP1105 in Combined Hyperlipidemic Patients With High Risk for CHD
An Efficacy and Safety Study of HCP1105 Capsule in Combined Hyperlipidemic Patients With High Risk for Coronary Heart Disease (CHD): A Randomized,Double-blind, Multicenter, Phase 3 Study
1 other identifier
interventional
270
1 country
1
Brief Summary
To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic patients with high risk for CHD.
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 11, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedSeptember 16, 2015
September 1, 2015
1.3 years
September 11, 2015
September 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Mean rate of change of non-HDL-C (%) from baseline
12 weeks
Secondary Outcomes (9)
Mean rate of change of HDL-C (%) from baseline
4, 8, 12 weeks
Mean rate of change of LDL-C (%) from baseline
4, 8, 12 weeks
Mean rate of change of Triglyceride (%) from baseline
4, 8, 12 weeks
Mean rate of change of Total cholesterol (%) from baseline
4, 8, 12 weeks
Mean rate of change of Total apo A1 (%) from baseline
4, 8, 12 weeks
- +4 more secondary outcomes
Study Arms (2)
experimental sequence
EXPERIMENTALRun-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816
comparative sequence
PLACEBO COMPARATORRun-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg
Interventions
Eligibility Criteria
You may qualify if:
- age 19≤
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
You may not qualify if:
- History of clinically significant hypersensitivity reaction with HMG-CoA reductase inhibitor and Omega-3
- Subject who has active liver disease and severe liver failure(Continuous elevation of AST,ALT level with unspecified cause or AST, ALT level exceeds more than three times of maximum upper range.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Euljii General Hospital
Seoul, Seoul, 139-711, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jung-yeol Park, M.D., Ph.D.
Asan Medecal Center
Central Study Contacts
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
September 11, 2015
First Posted
September 16, 2015
Study Start
October 1, 2014
Primary Completion
January 1, 2016
Study Completion
February 1, 2016
Last Updated
September 16, 2015
Record last verified: 2015-09