Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3-acids Ethylesters 90 in Type Ⅱb Hyperlipidemia

Efficacy and Safety of Co-administration of Omacor Plus Atorvastatin Compared With Atorvastatin Monotherapy in Patients With Type Ⅱb Dyslipidemia: a Multicenter, Double-blind, Randomized, Active-controlled, Parallel, Phase Ⅲ Study

The purpose of this study is to evaluate the efficacy and safety of combination therapy of omega-3-acids ethylesters 90/Atorvastatin calcium in type Ⅱb hyperlipidemia

Inclusion Criteria:

• LDL≥160mg/dl, 200mg/dl≤TG<500mg/dl
• In the case of smokers, he agrees should be smoke-free
• In the case of women of childbearing age, urine pregnancy test must be negative

Exclusion Criteria:

• Patients with acute artery disease within 3 months
• History of revascularization procedure or aneurism operation within 6months
• Patients with myopathy, rhabdomyolysis
• Patients with pancreatitis
• Patients with HIV positive
• History of malignant tumor within 2 years
• Patients must be treated with medications prohibited for concomitant use during study period
• Patients with uncontrolled hypertension(SBP>180mmHg or DBP>110mmHg)
• Serum Creatinine>1.2mg/dl(female), >1.4mg/dl(male)
• AST or ALT > 2X ULN
• CPK > 2X ULN
• Patients with galactose intolerance or Lapp lactase deficiency, glucose-galactose malabsorption
• Allergy or Hypersensitive to investigational drug
• History of drug or alcohol abuse within 2 years
• In the case of smokers, who do not intend to non smoking
• Women with pregnant, breast-feeding
• Patients treated with any investigational drugs within 1 month at the time consents are obtained
• Not eligible to participate for the study at the discretion of investigator