Clinical Trial to Evaluate the Efficacy and Safety of CKD-391

Study Overview
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Brief Summary
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A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.

Detailed Description
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The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.

Official Title
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A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Factorial Design, Phase III Clinical Trial To Evaluate the Efficacy and Safety of Atorvastatin+Ezetimibe Combination Therapy and Atorvastatin Monotherapy in Patients With Primary Hypercholesterolemia

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Drug: Atorvastatin10mg, Ezetimibe10mg
* Drug: Atorvastatin10mg, Ezetimibe placebo
* Drug: Atorvastatin20mg, Ezetimibe10mg
* Drug: Atorvastatin20mg, Ezetimibe placebo
* Drug: Atorvastatin40mg, Ezetimibe10mg
* Drug: Atorvastatin40mg, Ezetimibe placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, at least 19 years of age. Hyperlipidemia patient of LDL-C≤250 mg/dl and TG ≤400 mg/dl Patients requiring anti-dyslipidemia drug therapy [based on the NCEP ATP III(2002)] Drug compliance during Run-in period ≥70% Patients must willing to the study and signed an informed consent Exclusion Criteria: Patients with myopathy included rhabdomyolysis or CPK level≥2xULN Patients with acute arterial disease Patients with renal dysfunction or Serum creatinine level ≥2x ULN Patients with liver dysfunction or ALT, AST level > 2xULN Patients with medical history within 6 months prior to screening visit (Heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease) Patient with uncontrolled disease (diabetes mellitus as HbA1c level of > 9.0%, hypertension as SBP≥180mmHg or DBP≥110mmHg, hypothyroidism as TSH≥1.5xULN) Patients who have a history or presence of active malignancy within 5 years Patients with difficulty of stop taking lipid-lowering agents during run-in period. Patients who have taken another investigational drug within 4 weeks prior to screening visit.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin10mg, Ezetimibe10mg<br>Atorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks) | Drug: Atorvastatin10mg, Ezetimibe10mg<br>* Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)<br>* Other names: CKD-391;|
| Active Comparator: Atorvastatin10mg, Ezetimibe placebo<br>Atorvastatin10mg, placebo will be administered (Duration 8 weeks) | Drug: Atorvastatin10mg, Ezetimibe placebo<br>* Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)<br>* Other names: Lipitor;|
| Experimental: Atorvastatin20mg, Ezetimibe10mg<br>Atorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks) | Drug: Atorvastatin20mg, Ezetimibe10mg<br>* Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)<br>* Other names: CKD-391;|
| Active Comparator: Atorvastatin20mg, Ezetimibe placebo<br>Atorvastatin20mg, placebo will be administered (Duration 8 weeks) | Drug: Atorvastatin20mg, Ezetimibe placebo<br>* Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)<br>* Other names: Lipitor;|
| Experimental: Atorvastatin40mg, Ezetimibe10mg<br>Atorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks) | Drug: Atorvastatin40mg, Ezetimibe10mg<br>* Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)<br>* Other names: CKD-391;|
| Active Comparator: Atorvastatin40mg, Ezetimibe placebo<br>Atorvastatin40mg, placebo will be administered (Duration 8 weeks) | Drug: Atorvastatin40mg, Ezetimibe placebo<br>* Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)<br>* Other names: Lipitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change form baseline in LDL-C |  | up to week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change form baseline in LDL-C |  | up to week 20 | 
| Change form baseline in Total cholesterol |  | up to week 20 | 
| Change form baseline in Triglyceride |  | up to week 20 | 
| Change form baseline in HDL-C |  | up to week 20 | 
| Change form baseline in Non-HDL-C |  | up to week 20 | 
| Change form baseline in LDL-C/HDL-C ratio |  | up to week 20 | 
| Change form baseline in TC/HDL-C ratio |  | up to week 20 | 
| Change form baseline in Non-HDL-C/HDL-C ratio |  | up to week 20 | 
| Change form baseline in Apo-B ratio |  | up to week 20 | 
| Change form baseline in Apo-B |  | up to week 20 | 
| Change form baseline in Apo-A1 |  | up to week 20 | 
| Change form baseline in Apo-B/Apo-A1 ratio |  | up to week 20 |