A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia

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 Pitavastatin versus Pitavastatin/Fenofibrate in complex-dyslipidemia patients.

Detailed Description
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The purpose of this study is to demonstrate the efficacy of the Pitavastatin/Fenofibrate in complex-dyslipidemia patients by the reduction of non-HDL-Cholesterol levels compared with Pitavastatin.

Official Title
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A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin Versus Pitavastatin/Fenofibrate in Complex-dyslipidemia Patients

Conditions
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Complex-dyslipidemia

Intervention / Treatment
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* Drug: HL-PIF cap.160/2mg + Placebo
* Drug: Livalo tab. 2mg + Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High risk patient to Coronary Heart Disease At visit 1(Screening) If treated with Pitavastatin 2mg monotherapy 4 weeks prior to this study : LDL-C<100mg/dL and 150mg/dL≤TG<500mg/dL, randomize without run-in period If non treated with Pitavastatin 2mg monotherapy 4 weeks prior to this study : LDL-C≥100mg/dL and 150mg/dL≤TG<500mg/dL, treatment of Pitavastatin 2mg for 4 weeks(run-in period) LDL-C<100mg/dL and 150mg/dL≤TG<500mg/dL after 4 weeks of Pitavastatin 2mg monotherapy Exclusion Criteria: Subject with acute artery disease Subject with congestive heart failure(NYHA class III IV) or uncontrolled arrhythmia Secondary or iatrogenic dyslipidemia caused by hypothyroidism, nephrotic syndrome etc. AST or ALT > 2XULN, Serum Creatinine > 2.5mg/dL, Creatinine phosphokinase > 2XULN Subject with gall bladder disease or pancreatitis Uncontrolled hypertension Endocrine or metabolic disease affected on serum lipid or liprotein Subject with medical history of myopathy or rhabdomyolysis caused by Statin treatment, hereditary myopathy or family history Not eligible to participate for the study at the discretion of investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HL-PIF cap.160/2mg + Placebo<br>Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg once a day | Drug: HL-PIF cap.160/2mg + Placebo<br>* Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg<br>* Other names: Fenofibrate 160mg/Pitavastatin Ca 2mg;|
| Active Comparator: Livalo tab. 2mg + Placebo<br>Pitavastatin ca 2mg once a day | Drug: Livalo tab. 2mg + Placebo<br>* Pitavastatin ca 2mg<br>* Other names: Pitavastatin Ca 2mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean percentage change of Non-HDL Cholesterol | Change rate of Non-HDL-C after 8 weeks compared to baseline (%) | from baseline at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean percentage change of Non-HDL Cholesterol | Change rate of Non-HDL-C after 4 weeks compared to baseline (%) | from baseline at week 4 | 
| The mean percentage change of LDL-C | Change rate of LDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| The mean percentage change of HDL-C | Change rate of HDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| The mean percentage change of LDL-C/HDL-C | Change rate of LDL-C/HDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| The mean percentage change of TC/HDL-C | Change rate of TC/HDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| The mean percentage change of non-HDL-C/HDL-C | Change rate of non-HDL-C/HDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| The mean percentage change of VLDL-C | Change rate of VLDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| The mean percentage change of TG | Change rate of TG after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| The mean percentage change of TC | Change rate of TC after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| The mean percentage change of Apo Al | Change rate of Apo Al after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| The mean percentage change of Apo B | Change rate of Apo B change after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| The mean percentage change of Apo Al/Apo B | Change rate of Apo Al/Apo B after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| The mean percentage change of fibrinogen | Change rate of fibrinogen after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| The mean percentage change of hs-CRP | Change rate of hs-CRP after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | 
| Achievement rate(%) of treatment goals after 4 weeks and 8 weeks | LDL-C<100mg/dL & non-HDL-C <130mg/dL | from baseline at week 4,8 |