The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
196
Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks
Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6
\[(6 week value - baseline value)/baseline value\]\*100%.
Time frame: 6 weeks
Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6
\[(6 week value - baseline value)/baseline value\]\*100%.
Time frame: 6 weeks
Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
\[(6 week value - baseline value)/baseline value\]\*100%.
Time frame: 6 Weeks
Percent Change From Baseline in Total-Cholesterol at Week 6
(\[6 week value - baseline value)/baseline value\]\*100%.
Time frame: 6 Weeks
Percent Change From Baseline in Triglycerides (TG) at Week 6
\[(6 week value - baseline value)/baseline value\]\*100%.
Time frame: 6 weeks
Percent Change From Baseline in Apolipoprotein B at Week 6
\[(6 week value - baseline value)/baseline value\]\*100%.
Time frame: 6 Weeks
Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
\[(6 week value - baseline value)/baseline value\]\*100%.
Time frame: 6 Weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
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Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.
\[(6 week value - baseline value)/baseline value\]\*100%.
Time frame: 6 Weeks
Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6
\[(6 week value - baseline value)/baseline value\]\*100%.
Time frame: 6 Weeks
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
\[(6 week value - baseline value)/baseline value\]\*100%.
Time frame: 6 Weeks
Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6
\[(6 week value - baseline value)/baseline value\]\*100%.
Time frame: 6 Weeks
Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6
Time frame: 6 weeks