Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin

• Status: Unknown status
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Atorvastatin; Atorvastatin Calcium; Fenofibrate

Criteria

Inclusion Criteria:

• >19 years old

• High risk patient to Coronary Heart Disease (applied to 1 or more CHD risk factor listed below)

1. Patient with Coronary Heart Disease

2. Patient with carotid artery disease, peripheral blood vessel disease, abdominal aneurysm

3. Patient with diabetes(HbA1C≤9.0%)

4. 10-year risk of CHD >20%(by Framingham 10-year risk score calculation)

• At Visit 1(Screening)

1. 100mg/dl≥LDL-C, 150mg/dl≤TG≤500mg/dl

• 4weeks of Atorvastatin 20mg monotherapy run-in period

2. LDL-C<100mg/dl, 150mg/dl≤TG≤500mg/dl

• If treated with Atorvastatin 20mg monotherapy 4weeks prior to this study

• At Visit 2(After 4weeks of Atorvastatin monotherapy run-in period)

• LDL<100mg/dl, 150mg/dl≤TG≤500mg/dl

Exclusion Criteria:

• Patients with acute artery disease within 3 months

• Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months

• Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg)

• TSH>1.5X ULN

• Patients with myopathy, rhabdomyolysis or CK>2X ULN

• Hypersensitive to Atorvastatin and/or Fenofibrate or had photoallergy or phototoxicity during fibrate and/or ketoprofen treatment

• Serum Creatinine>2.5mg/dl, AST or ALT > 2X ULN

• History of drug or alcohol abuse within 6 months

• History of GI tract surgery or disability to drug absorption

• Women with pregnant, breast-feeding

• Patients with gallbladder disease

• Patients with biliary cirrhosis

• Patients with pancreatitis(acute pancreatitis is excluded due to severe hypertriglyceridemia)

• Patients treated with any investigational drugs within 4 weeks at the time consents are obtained

• History of malignant tumor including leukemia, lymphoma within 5 years

• Patients must be treated with medications prohibited for concomitant use during study period

• Not eligible to participate for the study at the discretion of investigator