To investigate the efficacy and safety of K-877 Extended Release 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with Statin Intolerant\* Hypercholesterolemia,using placebo as a controll. \*Statin Intolerant: Adverse events associated with statin use that cause unacceptable disturbances in the user's daily life, resulting in drug discontinuation or dose reduction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
71
K-877 0.2mg tablet
K-877 0.2mg tablet
Placebo tablet
Nakayama Clinic
Aichi, Japan
Kohnodai Hospital, National Center for Global Health and Medicine
Chiba, Japan
Percent change from baseline in LDL-C (formula F).
Percent change = (measured value at each time point - baseline value) / baseline value
Time frame: 4, 8, and 12 weeks after administration
Efficacy: % change from baseline in fasting serum LDL-C (mg/dL)(Direct)
Time frame: 4, 8, and 12 week after administration
Efficacy: % change from baseline in fasting serum HDL-C (mg/dL)
Time frame: 4, 8, and 12 week after administration
Efficacy: % change from baseline in fasting serum non HDL-C (mg/dL)
Time frame: 4, 8, and 12 week after administration
Efficacy: % change from baseline in fasting serum TG (mg/dL)
Time frame: 4, 8, and 12 week after administration
Efficacy: % change from baseline in fasting serum LDL-C(formula F)/HDL-C
Time frame: 4, 8, and 12 week after administration
Efficacy: % change from baseline in fasting serum non HDL-C/HDL-C
Time frame: 4, 8, and 12 week after administration
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