Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)
Merck Sharp & Dohme Corp.
This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to
atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in
Korea. The primary hypothesis being tested is that daily administration of Vytorin will
result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration
from baseline after 6 weeks treatment compared to atorvastatin.
IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)
Merck Sharp & Dohme Corp.
This is a randomized, active-control, double-blind study of subjects with stabilized
high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical
benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in
the United States) compared with Simvastatin 40 mg. As per the original protocol, if
low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin
in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011
protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new
increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the
reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV)
death, major coronary events, and stroke.
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