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Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia — HM-SIM4  

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)

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01564875
Study type Interventional
Source Hanmi Pharmaceutical Company Limited
Contact
Status Active, not recruiting
Phase Phase 4
Start date December 2010
Completion date May 2012
View Details
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