Efficacy and Safety of Fenofibrate added on to Atorvastatin compared with Atorvastatin in Mixed Hypercholesterolemic Patient

Not Applicable

Recruiting

Conditions: Endocrine, nutritional and metabolic disease

Registration Number: KCT0000963

Lead Sponsor: Chong Kun Dang

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 476

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

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean percent change of Non-HDL Cholesterol

Secondary Outcome Measures

Name	Time	Method
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