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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kuhnil Pharmaceutical Co., Ltd.
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

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