Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia

Efficacy and Safety of Combination Therapy of Rosuvastatin and Fenofibrate Versus Rosuvastatin Monotherapy in Mixed Dyslipidemia Patients

Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center, double-blind, phase 3 study

Inclusion Criteria:

• 19 ~ 80 years old

• High risk patient to Coronary Heart Disease

• At Visit 1(Screening)

  1. Treated with Rosuvastatin 10mg monotherapy 4weeks prior to this study
  2. 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl

• At Visit 2 (Baseline), 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl

Exclusion Criteria:

• AST or ALT > 2X ULN
• Patients with uncontrolled hyperthyroidism (TSH>1.5X ULN)
• Patients with uncontrolled diabetes (HbA1c ≥ 9%)
• Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg)
• Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months
• Patients treated with any investigational drugs within 3 months at the time consents are obtained
• Not eligible to participate for the study at the discretion of investigator