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

Kuhnil Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Hyperlipidemia, Familial Combined

Treatments: Other: Placebo(Omega-3-acids ethylesters 90); Drug: Omega-3-acids ethylesters 90 4g; Drug: Atorvastatin 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02035215

13-OM-8302

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g

Experimental group

Description:

Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d

Treatment:

Drug: Atorvastatin 20mg

Drug: Omega-3-acids ethylesters 90 4g

Atorvastatin 20mg, Placebo

Placebo Comparator group

Description:

Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d

Treatment:

Drug: Atorvastatin 20mg

Other: Placebo(Omega-3-acids ethylesters 90)