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

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.

Timeline

Start

2010-12

Primary completion

2012-05

Completion

2012-05

Publications

• Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

Drugs

Indications