Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.

Detailed Description
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Multi center, randomized, double-blind, parallel-group, therapeutic confirmatory study Primary Outcome Measure: The mean percent change of Non-HDL Cholesterol [Time Frame: from baseline at week 8] Secondary Outcome Measures: The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl [Time Frame: from baseline at week 8] The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B [Time Frame: from baseline at week 4, 8] The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI [Time Frame: from baseline at week 4, 8] The mean percent change of Fibrinogen, hs-CRP [Time Frame: from baseline at week 4, 8] Safety evaluation [Time Frame: Treatment period and Extension period]

Official Title
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Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin in Mixed Hypercholesterolemic Patient: Multi Center, Randomized, Double-blind, Parallel-group, Therapeutic Confirmatory Study.

Conditions
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Mixed Hyperlipidemia

Intervention / Treatment
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* Drug: Atorvastatin 20mg
* Drug: Fenofibrate 160mg
* Other: Placebo (Fenofibrate 160 mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >19 years old High risk patient to Coronary Heart Disease (applied to 1 or more CHD risk factor listed below) Patient with Coronary Heart Disease Patient with carotid artery disease, peripheral blood vessel disease, abdominal aneurysm Patient with diabetes(HbA1C≤9.0%) 10-year risk of CHD >20%(by Framingham 10-year risk score calculation) At Visit 1(Screening) 100mg/dl≥LDL-C, 150mg/dl≤TG≤500mg/dl 4weeks of Atorvastatin 20mg monotherapy run-in period LDL-C<100mg/dl, 150mg/dl≤TG≤500mg/dl If treated with Atorvastatin 20mg monotherapy 4weeks prior to this study At Visit 2(After 4weeks of Atorvastatin monotherapy run-in period) LDL<100mg/dl, 150mg/dl≤TG≤500mg/dl Exclusion Criteria: Patients with acute artery disease within 3 months Patients with congestive heart failure(NYHA class III IV) or uncontrolled arrhythmia within 6 months Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg) TSH>1.5X ULN Patients with myopathy, rhabdomyolysis or CK>2X ULN Hypersensitive to Atorvastatin and/or Fenofibrate or had photoallergy or phototoxicity during fibrate and/or ketoprofen treatment Serum Creatinine>2.5mg/dl, AST or ALT > 2X ULN History of drug or alcohol abuse within 6 months History of GI tract surgery or disability to drug absorption Women with pregnant, breast-feeding Patients with gallbladder disease Patients with biliary cirrhosis Patients with pancreatitis(acute pancreatitis is excluded due to severe hypertriglyceridemia) Patients treated with any investigational drugs within 4 weeks at the time consents are obtained History of malignant tumor including leukemia, lymphoma within 5 years Patients must be treated with medications prohibited for concomitant use during study period Not eligible to participate for the study at the discretion of investigator

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 |
| --- | --- |
| Experimental: Atorvastatin 20mg, Fenofibrate 160mg<br>Atorvastatin 20mg, Fenofibrate 160mg: po, q.d. | Drug: Atorvastatin 20mg<br>* [Atorvastatin Run-in Period] Take Atorvastatin 20mg 1 tablet once a day (after breakfast) [Treatment Period] Take Atrovastatin 20mg/Fenofibrate 160mg or Atorvastiatin 20mg/Placebo of Finofibrate 160mg 2 tablet once a day (after breakfast) [Extension Period] Take Atrovastatin 20mg, Fenofibrate 160mg 2 tablet once a day (after breakfast)<br>* Other names: Lipilou Tab.;Drug: Fenofibrate 160mg<br>* Refer to Intervention Description of Atorvastatin 20mg<br>|
| Active Comparator: Atorvastatin 20mg, Placebo<br>Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d. | Drug: Atorvastatin 20mg<br>* [Atorvastatin Run-in Period] Take Atorvastatin 20mg 1 tablet once a day (after breakfast) [Treatment Period] Take Atrovastatin 20mg/Fenofibrate 160mg or Atorvastiatin 20mg/Placebo of Finofibrate 160mg 2 tablet once a day (after breakfast) [Extension Period] Take Atrovastatin 20mg, Fenofibrate 160mg 2 tablet once a day (after breakfast)<br>* Other names: Lipilou Tab.;Other: Placebo (Fenofibrate 160 mg)<br>* Refer to Intervention Description of Atorvastatin 20mg<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean percent change of Non-HDL Cholesterol |  | from baseline at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl |  | from baseline at week 8 | 
| The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B |  | from baseline at week 4, 8 | 
| The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI |  | from baseline at week 4, 8 | 
| The mean percent change of Fibrinogen, hs-CRP |  | from baseline at week 4, 8 | 
| Safety evaluation (Physical examination, Vital sign, Laboratory, AE etc.) |  | Treatment period (8 weeks) and Extension period (16 weeks) |