The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/40 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 40 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
328
40 mg tablet administered orally once daily
10 mg tablet administered orally once daily
Ezetimibe/atorvastatin 10 mg/40 mg combination tablet administered orally once daily
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment
Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.
Time frame: Baseline and Week 6
Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment
Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.
Time frame: Baseline and Week 6
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment
Serum HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.
Time frame: Baseline and Week 6
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment
Non-HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.
Time frame: Baseline and Week 6
Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment
Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.
Time frame: Baseline and Week 6
Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment
Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.
Time frame: Baseline and Week 6
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Administered orally once daily
Administered orally once daily
Administered orally once daily