The purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.
This study is a long-term extension study of the protocol P00692 parent study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Ezetimibe 10 mg tablets
Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg
Placebo tablets matched to ezetimibe
Percentage of Participants Experiencing ≥1 Adverse Event (AE)
Time frame: Up to 12 months
Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE)
Time frame: Up to 12 months
Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Triglyceride Levels
Time frame: Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Total Cholesterol (TC)
Time frame: Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Calculated Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and 1.5, 3, 6, 9, and 12 months
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