Dyslipidemia in Cardiovascular Disease

Study Overview
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Brief Summary
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A multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy and safety of LipiLou 20 mg versus Lipitor 20 mg in hypercholesterolemic patients with higher risk cardiovascular disease in Korea.

Official Title
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A Multi-center, Randomized, Double-blinded Equivalence Clinical Trial to Evaluate Efficacy and Safety of LipiLou 20 mg Versus Lipitor 20 mg in Hypercholesterolemic Patients With Higher Risk Cardiovascular Disease in Korea

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: Atorvastatin (Lipilou)
* Drug: Atorvastatin (Lipitor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dyslipidemic patients with high-risk cardiovascular disease meeting more than 1 requirement below (LDL-C ≥ 100mg/dL) 1) Coronary artery disease diagnosed with atheroma in Coronary CT or Angiography, or SPECT positive or Treadmill test positive 2) Diabetes Mellitus 3) intervened with stent in coronary artery disease more than 1 year before 4) diagnosed with atheroma in carotid artery 5) Peripheral artery disease Aged 20 85 years Volunteers consented with participating clinical trial and submitted consent paper Exclusion Criteria: Experimental examination at screening 1) Active liver disease or more than 2 x ULN of AST/ALT 2) Creatine Kinase > 2 x ULN 3) Creatinine > 2.5mg/dL 4) Triglycerides > 500mg/dL intervened with stent in coronary artery disease less than 1 year before Hyper-sensitive or resistant to other HMG-CoA reductase inhibitors, or experienced serious adverse events Patients taking dyslipidemic treatments within 4 weeks (HMG-CoA reductase inhibitors, fibrates, nicotinic acids or bile acid resins, etc.) As uncontrolled DM patients, HbA1c≥11% or fasting plasma glucose ≥200mg/dL DBP > 100mmHg, SBP > 160mmHg Diagnosed with myopathy Appear to be a risk of myopathy below renal impairment or prior renal dysfunction hypothyroidism genetic defects or family history of myopathy experienced prior muscle toxicity with taking statins or fibrates prior liver disease or higher intakes of alcohol aged over 70, and a risk of myopathy Women pregnant or breast-feeding Women capable of pregnancy without using contraceptives contra-indicated medically or mentally, or forbidden legally Enrolled to other clinical trial within 4 weeks Impossible to participate clinical trial according to investigator's decision

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipilou 20mg<br> | Drug: Atorvastatin (Lipilou)<br>* treatment of dyslipidemia administration : PO, qod<br>|
| Active Comparator: Lipitor 20mg<br> | Drug: Atorvastatin (Lipitor)<br>* treatment of dyslipidemia administration : PO, qod<br>* Other names: Lipitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C |  | after taken medicine for 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia