Efficacy/Safety of HCP1306 Tablet Versus HGP0816 Tablet in Patients With Primary Hypercholesterolemia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with primary hypercholesterolemia.

Official Title
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A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1306 Tablet in Patients With Primary Hypercholesterolemia

Conditions
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Primary Hypercholesterolemia

Intervention / Treatment
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* Drug: HGP0816 5mg
* Drug: HGP0816 10mg
* Drug: HGP0816 20mg
* Drug: HCP1306 5/10mg
* Drug: HCP1306 10/10mg
* Drug: HCP1306 20/10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 19 years Signed informed consent At visit 1, LDL-C ≤ 250mg/dL and Triglyceride < 400 mg/dL After 4 weeks more TLC, At visit2, LDL-C ≤ 250mg/dL, Triglyceride < 400 mg/dL and satisfied criteria according to Risk of cardiovascular disease Exclusion Criteria: Current or past history of hypersensitivity to HMG-CoA reductase inhibitors and component of Ezetimibe Has an active liver disease and severe liver disorder (continous elevation of AST, ALT level or exceeds more than 3 times of normal upper limit) Has a severe renal failure and kidney injury (Creatinine level exceeds more than 2 times of normal upper limit) CK level exceeds more than 5 times of normal upper limit Uncontrolled hypertension patient (SBP≥ 180 mmHg or DBP ≥ 110 mmHg) Uncontrolled diabetes mellitus patient (HbA1c ≥ 9%) Uncontrolled malfunctional thyroidism (or at pre-visit 2, TSH level exceeds more than 1.5 times of normal upper limit)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HGP0816 5mg<br> | Drug: HGP0816 5mg<br>* P.O.<br>|
| Active Comparator: HGP0816 10mg<br> | Drug: HGP0816 10mg<br>* P.O.<br>|
| Active Comparator: HGP0816 20mg<br> | Drug: HGP0816 20mg<br>* P.O.<br>|
| Experimental: HCP1306 5/10mg<br> | Drug: HCP1306 5/10mg<br>* P.O.<br>|
| Experimental: HCP1306 10/10mg<br> | Drug: HCP1306 10/10mg<br>* P.O.<br>|
| Experimental: HCP1306 20/10mg<br> | Drug: HCP1306 20/10mg<br>* P.O.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 8 week in LDL-Cholesterol |  | baseline and 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 4 week in LDL-Cholesterol |  | baseline and 4 week | 
| Percentage of patients reaching treatment goals according to NCEP ATP III Guideline |  | week 4, week 8 | 
| Percent change from baseline to 4 week and 8 week in TC |  | week 4, week 8 | 
| Percent change from baseline to 4 week and 8 week in HDL-C |  | week 4, week 8 | 
| Percent change from baseline to 4 week and 8 week in TG |  | week 4, week 8 |