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

Study Overview
=================
Brief 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

Official Title
-----------------
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

Conditions
-----------------
Hyperlipidemia, Familial Combined

Intervention / Treatment
-----------------
* Drug: Atorvastatin 20mg
* Drug: Omega-3-acids ethylesters 90 4g
* Other: Placebo(Omega-3-acids ethylesters 90)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g<br>Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d | Drug: Atorvastatin 20mg<br> <br> * Other names: Lipitor 20mg;Drug: Omega-3-acids ethylesters 90 4g<br> <br> * Other names: Omacor Soft Capsule 4g;|
| Placebo Comparator: Atorvastatin 20mg, Placebo<br>Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d | Drug: Atorvastatin 20mg<br> <br> * Other names: Lipitor 20mg;Other: Placebo(Omega-3-acids ethylesters 90)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean percent change of Triglyceride(TG) |  | from baseline at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean percent change of Triglyceride(TG) |  | from baseline at week 4 | 
| The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C |  | from baseline at week 4,8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperlipidemia, Familial Combined, Omega 3 acids ethylesters 90, Atorvastatin