Study design * Multicenter, double-dummy, double-blinded, randomized, Phase 4 study * Patients will be randomized to either a study group or a control group in a 1:1 ratio, and will be orally administered the assigned drugs Study Objective -The study is designed to demonstrate that efficacy and safety of morning dosing of Simvast Controlled Release (CR) Tab is not inferior to evening dosing of Zocor Tab in patients with stage 3,4,5 chronic kidney disease with hyperlipidemia Primary objective -to assess the percent change of LDL-C at Week 8 from baseline in Chronic Kidney Disease(CKD) stage 3,4,5 with hyperlipidemia subjects.
The secondary objectives of the study are as follows: * to assess the change and percent change of TC, HDL-C, TG from baseline. * to assess the accomplishment rate of therapeutic goals based on the therapeutic guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
122
Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m.
Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m.
Hallym University Medical Center
Anyang-si, Gyeonggi-do, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Eulji General Hospital
Seoul, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Percent change of LDL-C
Percent change of LDL-C at Week 8 from baseline
Time frame: 8 weeks
Change and percent change of TC, HDL-C, TG
Change and percent change of TC, HDL-C, TG from baseline.
Time frame: 8 weeks
Accomplishment rate of therapeutic goals
-Accomplishment rate of therapeutic goals based on the therapeutic guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis.
Time frame: 8 weeks
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