The Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

Study Overview
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Brief Summary
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A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients with Primary Hypercholesterolemia

Official Title
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A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Ezetimibe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 19 years or older Patients with primary hypercholesterolemia Patients who were informed about the purpose, method, effects, risks of this clinical study and have provided a written consent form signed by him/herself or by a representative those who show an LDL-C level of 250 mg/dL or below and a TG level of less than 350 mg/dL at the run-in period (Week -1), and fall under the criterion of requiring the administration of antidyslipidemic drug of NCEP ATP III Exclusion Criteria: Patients with hypersensitivity to the investigational product or its ingredients Those with an uncontrolled hypertension (SBP ≧ 180 mmHg or DBP ≧ 100 mmHg) Those with a history of unstable angina, myocardial infarction, transient ischemic attack, cerebral vascular disease, coronary artery bypass or coronary intervention within 3 months of screening date Those with a history of malignant tumor within 5 years Those with a history of myopathy or rhabdomyolysis Those who show clinically significant confirmed laboratory test results (1) Patients showing AST or ALT level of greater than 2 times the institutional upper limit of normal or those with active liver disease or chronic hepatitis (2) A serum creatinine level greater than 2 times the institutional upper limit of normal (3) HbA1c > 9% (4) Those with TSH level of greater than 1.5 times the institutional upper limit of normal (5) Those with CK level greater than 2 times the institutional upper limit of normal (However, except for an increase caused by a recent trauma, intramuscular injection or strenuous exercise) Those who were given, within 4 weeks prior to the baseline (8 weeks in case of fibrate) or are expected to be given during the study period, a drug that can have an effect on the efficacy assessment of the clinical study (eg: antidyslipidemic drug (statins, ezetimibe, fibrates, BAS, nicotinic acid and derivative, etc.), systemic glucocorticosteroids, steatolytic enzyme inhibitor, cyclosporine, HIV proteinase inhibitor, macrolide class antibiotics, etc.) Patients who were given estrogen within 3 months from the screening or those who are expected to be given an administration during the study period. (However, a patient who is under a hormone replacement therapy (HRT) will be allowed if no dose change is expected in the course of the clinical study.) Those with a history of alcohol or drug abuse Patients with a hereditary disorder of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption Pregnant or breast-feeding women Women of childbearing potential or men who do not intend to use an adequate contraceptive measure during the study period and for 4 weeks after the end of the study(Adequate contraception: Administration and transplantation of a progestin-only contraceptive pill, intrauterine device, condom, spermicidal agent, etc.) Patients who participated in another clinical study within 3 months from the screening date or have not had a washout period of at least 5 times the half-life of the active ingredient of the previously administered investigational product, whichever is longer Those with drug malabsorption Patients who has been judged by the investigator to be ineligible to participate in the clinical study

Ages Eligible for Study
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Minimum Age: 19 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RSV5mg + EZE 10mg<br>Rosuvastatin 5mg/Ezetimibe 10mg | Drug: Rosuvastatin<br> <br> Drug: Ezetimibe<br> <br> |
| Active Comparator: RSV5mg<br>Rosuvastatin 5mg | Drug: Rosuvastatin<br> <br> |
| Experimental: RSV10mg + EZE10mg<br>Rosuvastatin 10mg/ Ezetimibe 10mg | Drug: Rosuvastatin<br> <br> Drug: Ezetimibe<br> <br> |
| Active Comparator: RSV10mg<br>Rosuvastatin 10mg | Drug: Rosuvastatin<br> <br> |
| Experimental: RSV20mg + EZE10mg<br>Rosuvastatin 20mg/Ezetimibe 10mg | Drug: Rosuvastatin<br> <br> Drug: Ezetimibe<br> <br> |
| Active Comparator: RSV20mg<br>Rosuvastatin 20mg | Drug: Rosuvastatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 8 week in LDL-Cholesterol |  | baseline and 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 4 week in LDL-Cholesterol |  | baseline and 4 week | 
| The change in the LDL-C level from the baseline to Week 4 and Week 8 |  | baseline to 4 and 8 week | 
| The change and percent change in the levels of TC, TG, HDL-C, non-HDL-C, apolipoprotein B, and hs-CRP from the baseline to Week 4 and Week 8 |  | baseline to 4 and 8 week | 
| The change and percent change in the ratios of LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, and Apo B/Apo A-I from the baseline to Week 4 and Week 8 |  | baseline to 4 and 8 week | 
| The ratio of the subjects who have reached the target LDL-C level according to the NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Week 4 and Week 8 |  | baseline to 4 and 8 week |