Chronic Kidney Disease Clinical Trial
Official title:
Efficacy and Safety of Morning Intake of Simvast Controlled Release (CR) Tablet Versus Evening Intake of Zocor Tablet in Chronic Kidney Disease Stage(CKD)3, 4 and 5 Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 4 Trial (HM-SIM4)
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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