Comparison of the Efficacy and Safety of AtorVastatin mOnotherapy vs. Combination Atorvastatin/Fenofibric Acid

Study Overview
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Brief Summary
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The purpose of this study is to compare combination atorvastatin/fenofibric acid 10/135mg with atorvastatin 20mg monotherapy in the mixed hyperlipidemia who were not at lipid goals with atorvastatin 10mg monotherapy.

Detailed Description
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Study conduct according to the standard operating procedure The sponsor, the investigator, and all other persons involved in the study at the study center or other facilities should conduct the study in accordance with the study protocol, each standard operating procedure, and Korea Good Clinical Pratice. Data quality control In order to ensure the reliability of all study-related data and their appropriate processing, the sponsor will apply quality control to each step of data handling Monitoring In order to confirm that the study is being conducted, recorded and reported according to the study protocol and International Conference on Harmonization Good Clinical Practice(ICH-GCP), the sponsor or CRO will perform monitoring of study procedure. In monitoring, the monitors will cross check the description in the case report form, etc. against study-related records such as source documents to confirm that the description is accurate. Measures taken to cope with adverse events and reporting procedure The investigator should notify the event to the sponsor or Contract Research Organization(CRO) immediately (within around 24 hours) after having noticed the occurence of a serioius adverse event by telephone, fax or E-mail. The investigator should complete and submit an serioius adverse event(SAE) report form containing all information to the Institutional Review Board (IRB). Data Management In this study, data will be collected in electronic Case Report Form(CRF) Data validation for missing data will be managed by computer programming and manual check.

Official Title
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Comparison of the Efficacy and AtorVastatin 20mg mOnotherapy Versus Combination Atorvastatin/Fenofibric Acid 10/135mg in the Mixed hyperlipiDemia Who Were Not at Lipid gOals With Atorvastatin 10mg Monotherapy.

Conditions
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Mixed Hyperlipidemia

Intervention / Treatment
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* Drug: Atorvastatin 10mg, fenofibric acid 135mg
* Drug: atorvastatin 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients of the age of 20years or older patients who have been taking atorvastatin 10mg 1 tab per day for more than 8 weeks before screening patients who meet the following criteria Low density lipoproteins-cholesterol level < 130mg/dL 150mg/dL < Triglyceride level < 500mg/dL HDL-cholesterol level < 45mg/dL patients who consent for the consent before enrolling the study Exclusion Criteria: Allergic to HMG-CoA reductase inhibitor and fibrates uncontrolled Hypertension unstable angina, myocardial infarction, transient ischemic attack uncontrolled diabetes thyroid disease myopathy, rhabdomyolysis history alcoholic chronic diarrhea, gastrointestinal disease malignant tumor patients who are pregnant lactating woman

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| Active Comparator: Atorvastatin 20mg, monotherapy<br>Atorvastatin 20mg/day PO for 12weeks | Drug: atorvastatin 20mg<br>* Atorvastatin 20mg/day PO for 12weeks<br>* Other names: Newvast Tab. 20mg;|
| Experimental: Atorvastatin 10mg, Fenofibric acid 135mg<br>Atorvastatin 10mg, Fenofibric acid 135mg per day PO for 12weeks | Drug: Atorvastatin 10mg, fenofibric acid 135mg<br>* Atorvastatin 10mg, fenofibric acid 135mg/day PO for 12 weeks<br>* Other names: Newvast 10mg, Fenocid 135mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of non-HDL cholesterol | -change rate : [(12nd week non-High density lipoprotein - baseline non-High density lipoprotein) / baseline non-High density lipoprotein] * 100 | at screening and after 12 weeks | 
| levelresponse rate of non-HDL cholesterol level < 130mg/dL | -Response rate : (subjects who are at less than 130mg/dL of non-High density lipoprotein level / all subjects) * 100 | at screening and after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of TC,HDL-C,LDL-C,TG,Apo B/A1 |  | at screening and after 12 weeks | 
| Changes of Glucose, HbA1c, HOMA-IR level | HOMA-IR index = [fasting serum insulin(uU/mL) * fasting serum glucose(mmol/L)]/22.5 | at screening and after 12 weeks | 
| Changes of hs-CRP, adiponectin, resistin level |  | at screening and after 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperlipidemia, Atorvastatin, Fenofibric acid, combination, monotherapy