K-924 Phase III Confirmatory Study

Inclusion criteria

• Patients with hypercholesterolemia had to be age 20 years or older at written informed consent (ICF)
• Patients who have been on a diet and / or exercise regimen more than 12 weeks before the screening
• Those whose LDL-C (Friedewald formula) at the screening any of the following in the category classification based on Japan Atherosclerosis Society guidelines for prevention Atherosclerotic Cardiovascular Disease 2017

• Low risk of primary prevention : LDL-C => 160 mg/dL
• Medium risk of primary prevention : LDL-C => 140 mg/dL
• High risk of primary prevention : LDL-C => 120 mg/dL

Exclusion criteria

• Patients with a history of myopathy or rhabdomyolysis due to pitavastatin or ezetimibe
• Patients with a history of hypersensitivity due to pitavastatin or ezetimibe
• Patients with severe liver damage (Child Pugh Class B or higher) or biliary obstruction
• Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women who do not use specific contraceptive methods
• Patients whose CK is 3 times or more of the upper limit of the reference value at screening
• Patients whose AST and ALT is 2 times or more of the upper limit of the reference value at screening
• Patients wiht type 1 diabetes or uncontrolled type 2 diabetes as defined HbA1c 8% or more at screening
• Patients with uncontrolled hypertension as defined systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more at screening
• Patients with eGFR of less than 30 mL / min / 1.73 m² at screening or dialysis
• Patients with heart failure class III or higher according to NYHA cardiac function classification
• Patients with uncontrolled arrhythmia
• Patients with uncontrolled metabolic endocrine disease
• Patients with a history of coronary artery disease or patient with familial hypercholesterolemia
• Patients with malignant tumors or who are judged to have a high possibility of relapse
• Patients who have collected 200 mL or more within 4 weeks before screening, 400 mL or more of blood within 12 weeks for males or 16 weeks for females, or within 2 weeks for (Plasma component / platelet component)
• Persons with a history of severe drug allergy (anaphylactic shock, etc.)
• Patients who need contraindicated drugs during the study period after obtaining consent
• Patients with TG of 400 mg / dL or more at screening
• Patients who have LDL apheresis
• Patients with malabsorption or history, or who have undergone gastrointestinal surgery (excluding appendectomy, hernia treatment, etc.) that may affect absorption.
• Patients with Alcohol or drug addiction
• Patients who participate in other clinical trials within 16 weeks prior to study drug administration and who are administered non-placebo investigational drugs, or who participate in other clinical trials concurrently with this study
• Patients who have received K-924
• Patients who judged to be inappropriate by the Investigator or Investigator