Clinical Trial to Evaluate the Efficacy and Safety of CKD-391

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Factorial Design, Phase III Clinical Trial To Evaluate the Efficacy and Safety of Atorvastatin+Ezetimibe Combination Therapy and Atorvastatin Monotherapy in Patients With Primary Hypercholesterolemia

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.

The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.

Inclusion Criteria:

• Adult, at least 19 years of age.
• Hyperlipidemia patient of LDL-C≤250 mg/dl and TG ≤400 mg/dl
• Patients requiring anti-dyslipidemia drug therapy [based on the NCEP ATP III(2002)]
• Drug compliance during Run-in period ≥70%
• Patients must willing to the study and signed an informed consent

Exclusion Criteria:

• Patients with myopathy included rhabdomyolysis or CPK level≥2xULN
• Patients with acute arterial disease
• Patients with renal dysfunction or Serum creatinine level ≥2x ULN
• Patients with liver dysfunction or ALT, AST level > 2xULN
• Patients with medical history within 6 months prior to screening visit (Heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease)
• Patient with uncontrolled disease (diabetes mellitus as HbA1c level of > 9.0%, hypertension as SBP≥180mmHg or DBP≥110mmHg, hypothyroidism as TSH≥1.5xULN)
• Patients who have a history or presence of active malignancy within 5 years
• Patients with difficulty of stop taking lipid-lowering agents during run-in period.
• Patients who have taken another investigational drug within 4 weeks prior to screening visit.