The purpose of this study is to test the safety and effectiveness of MK-6213 as compared to MK-6213/Atorvastatin in participants 18 to 75 years) with high cholesterol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
334
MK-6213 160 mg for 4 weeks.
atorvastatin calcium 20mg for 4 weeks.
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Blood collected at baseline (predose) and after 4 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by reflex beta-quantitation method. The percentage change from baseline at Week 4 was summarized.
Time frame: Baseline (predose) and Week 4
Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized
Time frame: Up to 14 days post last dose of study drug (up to 6 weeks)
Percentage of Participants That Had Study Drug Discontinued Due to an AE
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized.
Time frame: up to 4 weeks
Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Blood collected at baseline (predose) and after 4 weeks of treatment to determine non-HDL-C levels. The percentage change from baseline at Week 4 was summarized.
Time frame: Baseline (predose) and Week 4
Percentage Change From Baseline in Apolipoprotein B (ApoB)
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Blood collected at baseline (predose) and after 4 weeks of treatment to determine ApoB levels. The percentage change from baseline at Week 4 was summarized.
Time frame: Baseline (predose) and Week 4
Percentage Change From Baseline in Total Cholesterol (TC)
Blood collected at baseline (predose) and after 4 weeks of treatment to determine TC levels. The percentage change from baseline at Week 4 was summarized.
Time frame: Baseline (predose) and Week 4
Percentage Change From Baseline in HDL-C
Blood collected at baseline (predose) and after 4 weeks of treatment to determine HDL-C levels. The percentage change from baseline at Week 4 was summarized.
Time frame: Baseline (predose) and Week 4
Percentage Change From Baseline in TG
Blood collected at baseline (predose) and after 4 weeks of treatment to determine TG levels. The percentage change from baseline at Week 4 was summarized.
Time frame: Baseline (predose) and Week 4