To investigate the efficacy and safety of Pemafibrate 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with hypercholesterolemia and inadequate response to statins, using placebo as a control.
Patients with hypercholesterolemia aged 18 years or older at the time of obtaining written informed consent
Patients who have taken statins at a fixed dose and regimen within the approved dose range for at least four weeks prior to the first screening assessment.
Patients who have received stable dietary and/or exercise therapy for at least 12 weeks prior to the first screening assessment.
Patients with the fasting serum TG < 150 mg/dL on two consecutive occasions at screening
Patients who require administration of prohibited drugs during the post-marketing clinical trial period after written informed consent
Patients with type 1 diabetes and uncontrolled type 2 diabetes [HbA1c(NGSP) >= 10.0 % at Screening]
Patients whose LDL-C level changed by more than +20% or -20% in the second screening test compared to the the first.
Patients with uncontrolled thyroid disease
Parallel
Pemafibrate 0.2 mg/day
DrugAdministered orally once daily
Pemafibrate 0.4 mg/day
DrugAdministered orally once daily
Placebo
DrugAdministered orally once daily
Percentage change from baseline in LDL-C (direct)
Percent change = (measured value at each time point - baseline value) / baseline value
Achievement of lipid management targets based on the mean LDL-C (direct) values
Calculate the percentage of participants who achieved lipid management targets
Percentage change from baseline in LDL-C(Friedewald formula), HDL-C(direct), non-HDL-C, TC, TG
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