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

 1. Low density lipoproteins-cholesterol level < 130mg/dL

 2. 150mg/dL < Triglyceride level < 500mg/dL

 3. 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