The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia

Study Overview
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Brief Summary
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There will be no significant differences in the efficacy and tolerability between the test and reference formulations of atorvastatin 20 mg in these Korean adults with primary hypercholesterolemia.

Official Title
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Assessment of the Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia : A Multicenter, Prospective, Open-Label, Randomized, Trial

Conditions
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Dyslipidemia, Cardiovascular Disease, Hypercholesterolemia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the patients aged 20 to 79 years with primary hypercholesterolemia that was not sufficiently responsive to therapeutic lifestyle changes and had LDL-C level over 100 mg/dL in high risk group. Inclusion criteria was in accordance with drug treatment guidelines; coronary artery disease or equivalent group with LDL-C ≥100 mg/dl; patients with two or more risk factors and LDL-C≥130 mg/dl; patients with 0 or 1 risk factor and LDL-C >160 mg/dl after therapeutic lifestyle changes Exclusion Criteria: therapy with any other investigational drug within 30 days of randomization, history of hypersensitivity to HMG-CoA reductase inhibitors, uncontrolled hypertension, poorly controlled diabetes (glycosylated hemoglobin [HbA1c] >9%), unstable angina or presented with new-onset myocardial infarction (within 6 months), creatinine >2.5 mg/dl, alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), aspartate aminotransferase(AST) >2 x ULN, or creatine kinase (CK) >2 x ULN, history of malignancy or psychosis; chronic liver disease, drug or alcohol abuse, pregnancy, breastfeeding, failure to practice adequate contraception, cyclical hormonal contraceptives or intermittent use of hormone replacement therapies.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipinon-test formulation of atrovastain - 20mg<br> | Drug: Atorvastatin (Lipinon)<br>* treatment of dyslipidemia administration : PO, qod<br>|
| Active Comparator: Lipitor- branded formuation of atorvastatin-20mg<br> | Drug: Atorvastatin (Lipitor)<br>* treatment of dyslipidemia administration : PO, qod<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percent change of LDL-C level |  | After taken medication for 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percent change in total cholesterol, triglyceride, high density lipoprotein cholesterol (HDL-C) level, apolipoprotein B/A1 ratio, LDL/HDL ratio, small dense LDL fraction, high-sensitive C reactive protein (hs-CRP) |  | After taken medication for 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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statins, cholesterol, hypercholesterolemia, atorvastatin, Dyslipidemia in cardiovascular disease (KoLipinon)