Mixed Hyperlipidemia
Conditions
Keywords
Hyperlipidemia, Atorvastatin, Fenofibric acid, combination, monotherapy
Brief summary
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
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.
Interventions
DRUGAtorvastatin 10mg, fenofibric acid 135mg
Atorvastatin 10mg, fenofibric acid 135mg/day PO for 12 weeks
DRUGatorvastatin 20mg
Atorvastatin 20mg/day PO for 12weeks
Sponsors
Sang Hak Lee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of non-HDL cholesterol | at screening and after 12 weeks | -change rate : \[(12nd week non-High density lipoprotein - baseline non-High density lipoprotein) / baseline non-High density lipoprotein\] \* 100 |
| levelresponse rate of non-HDL cholesterol level < 130mg/dL | at screening and after 12 weeks | -Response rate : (subjects who are at less than 130mg/dL of non-High density lipoprotein level / all subjects) \* 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of hs-CRP, adiponectin, resistin level | at screening and after 12 weeks | — |
| Changes of Glucose, HbA1c, HOMA-IR level | at screening and after 12 weeks | HOMA-IR index = \[fasting serum insulin(uU/mL) \* fasting serum glucose(mmol/L)\]/22.5 |
| changes of TC,HDL-C,LDL-C,TG,Apo B/A1 | at screening and after 12 weeks | — |
Other
| Measure | Time frame |
|---|---|
| changes of BUN/Cr level | at screening and after 12 weeks |
| Changes of Homocysteine level | at screening and after 12 weeks |
Countries
South Korea
Outcome results
None listed