Clinical Trials Directory

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UnknownNCT01564875

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

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)

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
122 (actual)
Sponsor
Hanmi Pharmaceutical Company Limited · Industry
Sex
All
Age
20 Years – 75 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGSimvast CRSimvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m.
DRUGZocorZocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m.

Timeline

Start date
2010-12-01
Primary completion
2012-05-01
Completion
2012-05-01
First posted
2012-03-28
Last updated
2012-03-28

Locations

7 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01564875. Inclusion in this directory is not an endorsement.