Last updated on February 2015

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Mixed Hyperlipidemia
  • Age: Between 19 - 100 Years
  • Gender: Male or Female
  • Other:
    >19 years old
    High risk patient to Coronary Heart Disease (applied to 1 or more CHD risk factor
    listed below)
    Patient with Coronary Heart Disease
    Patient with carotid artery disease, peripheral blood vessel disease, abdominal
    Patient with diabetes(HbA1C≤9.0%)
    10-year risk of CHD >20%(by Framingham 10-year risk score calculation)
    At Visit 1(Screening)
    100mg/dl≥LDL-C, 150mg/dl≤TG≤500mg/dl
    4weeks of Atorvastatin 20mg monotherapy run-in period
    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

You may not be eligible for this study if the following are true:

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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