Evaluating the Efficacy and Safety of HCP1105 in Combined Hyperlipidemic Patients With High Risk for CHD

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic patients with high risk for CHD.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Hyperlipidemias

Intervention / Treatment
-----------------
* Drug: HCP1105
* Drug: HGP0816
* Drug: Placebo of HCP1105
* Drug: Placebo of HGP0816


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental sequence<br>Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816 | Drug: HCP1105<br>* Rosuvastatin + Omega-3-acids ethyl esters<br>Drug: HGP0816<br>* Rosuvastatin<br>Drug: Placebo of HGP0816<br>* Exclusion of Rosuvastatin in HGP0816<br>|
| Placebo Comparator: comparative sequence<br>Run-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg | Drug: HGP0816<br>* Rosuvastatin<br>Drug: Placebo of HCP1105<br>* Soybean Oil<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean rate of change of non-HDL-C (%) from baseline |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Mean rate of change of Total apo B (%) from baseline |  | 4, 8, 12 weeks | 
| Mean rate of change of Lipoprotein(a) (%) from baseline |  | 4, 8, 12 weeks | 
| Mean rate of change of hs-CRP (%) from baseline |  | 4, 8, 12 weeks | 
| Rate of the subjects who meet the target level of treatment | target level (Non-HDL-C<130mg/dL) | 4, 8, 12 weeks |