Efficacy/Safety of HCP1306 Tablet Versus HGP0816 Tablet in Patients With Primary Hypercholesterolemia

A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1306 Tablet in Patients With Primary Hypercholesterolemia

The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with primary hypercholesterolemia.

Inclusion Criteria:

• Aged over 19 years
• Signed informed consent
• At visit 1, LDL-C ≤ 250mg/dL and Triglyceride < 400 mg/dL
• After 4 weeks more TLC, At visit2, LDL-C ≤ 250mg/dL, Triglyceride < 400 mg/dL and satisfied criteria according to Risk of cardiovascular disease

Exclusion Criteria:

• Current or past history of hypersensitivity to HMG-CoA reductase inhibitors and component of Ezetimibe
• Has an active liver disease and severe liver disorder (continous elevation of AST, ALT level or exceeds more than 3 times of normal upper limit)
• Has a severe renal failure and kidney injury (Creatinine level exceeds more than 2 times of normal upper limit)
• CK level exceeds more than 5 times of normal upper limit
• Uncontrolled hypertension patient (SBP≥ 180 mmHg or DBP ≥ 110 mmHg)
• Uncontrolled diabetes mellitus patient (HbA1c ≥ 9%)
• Uncontrolled malfunctional thyroidism (or at pre-visit 2, TSH level exceeds more than 1.5 times of normal upper limit)