To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
579
Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
Atorvastatin 40 mg by mouth, once a day for 6 weeks
Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks.
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C
Percent Change in LDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%
Time frame: Baseline and 6 weeks
Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)
Percent Change in HDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%
Time frame: Baseline and 6 weeks
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
Percent Change in Non-HDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%
Time frame: Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Total-Cholesterol
Percent Change in Total-C = \[(week 6 value - baseline value)/baseline value\]\*100%
Time frame: Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Triglycerides (TG)
Percent Change in TG = \[(week 6 value - baseline value)/baseline value\]\*100%
Time frame: Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)
Percent Change in Apo B = \[(week 6 value - baseline value)/baseline value\]\*100%
Time frame: Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)
Percent Change in Apo A-I = \[(week 6 value - baseline value)/baseline value\]\*100%
Time frame: Baseline and 6 Weeks
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Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio
Percent Change in TC:HDL-C Ratio = \[(week 6 ratio - baseline ratio)/baseline ratio\]\*100%
Time frame: Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio
Percent Change in LDL-C:HDL-C Ratio = \[(week 6 ratio - baseline ratio)/baseline ratio\]\*100%
Time frame: Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio
Percent Change in Apo B:Apo A-I Ratio = \[(week 6 ratio - baseline ratio)/baseline ratio\]\*100%
Time frame: Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio
Percent Change in non-HDL-C:HDL-C Ratio = \[(week 6 ratio - baseline ratio)/baseline ratio\]\*100%
Time frame: Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)
Percent Change in CRP = \[(week 6 value - baseline value)/baseline value\]\*100%
Time frame: Baseline and 6 Weeks
Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
Time frame: 6 Weeks