None listed
Conditions
Interventions
Drug : * Experimental: Atorvastatin 20mg, 1 tab., po, q.d.
Fenofibrate 160mg, 1 tab., po, q.d.
* Comparator: Atorvastatin 20mg, 1 tab., po, q.d.
Placebo for Fenofibrate 1
Sponsors
Chong Kun Dang
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 19 years old and above 2. High risk patient to Coronary Heart Disease (applied to 1 or more CHD risk factor listed below) a.Patient with Coronary Heart Disease b.Patient with carotid artery disease, peripheral blood vessel disease, abdominal aneurysm c.Patient with diabetes(HbA1C=8.0%) d.10-year risk of CHD >20% (by Framingham 10-year risk score calculation) 3. At Visit 1(Screening) a.If not treated with Atorvastatin 20mg monotherapy without the change of dosage for 4 weeks and LDL-C=130mg/dl, 150mg/dl=TG=400mg/dl : 4weeks of Atorvastatin 20mg monotherapy run-in period b.If treated with Atorvastatin 20mg monotherapy without the change of dosage for 4 weeks prior to this study and LDL-C<100mg/dl, 150mg/dl=TG=400mg/dl : Randomization 4. At Visit 2(After 4weeks of Atorvastatin monotherapy run-in period) : LDL<100mg/dl, 150mg/dl=TG=400mg/dl
Exclusion criteria
Exclusion criteria: 1. Patients with acute artery disease within 3 months 2. Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months 3. Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg) 4. TSH>1.5X ULN 5. Patients with myopathy, rhabdomyolysis or CK>2X ULN 6. Hypersensitive to Atorvastatin and/or Fenofibrate or had photoallery or phototoxicity during fibrate and/or ketoprofen treatment 7. Serum Creatinine>2.5mg/dl, AST or ALT > 2X ULN 8. History of drug or alcohol abuse wtihin 6months 9. History of GI tract surgery or disability to drug absorption 10. Women with pregnant, breast-feeding 11. Patients with gallbladder disease 12. Patients with biliary cirrhosis 13. Patients with pancreatitis(acute pancreatitis is exlcuded due to severe hypertriglyceridemia) 14. Patients treated with any investigational drugs within 4 weeks at the time consents are obtained 15. History of malignant tumor including leukemia, lymphoma within 5 years 16. Patients must be treated with medications prohibited for concomitant use during study period 17. Not eligible to participate for the study at the discretion of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean percent change of Non-HDL Cholesterol | — |
Secondary
| Measure | Time frame |
|---|---|
| The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl;The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B ;The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI ;The mean percent change of Fibrinogen, hs-CRP | — |
Countries
Korea, Republic of
Contacts
Public ContactMihee Hwang
Samsung Medical Center
Outcome results
None listed