A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy, and Tolerability of MK-6213 Co-Administered With Atorvastatin in Patients With Primary Hypercholesterolemia

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: MK-6213
* Drug: Atorvastatin calcium
* Drug: Placebo for MK-6312 160 mg
* Drug: Placebo for Atorvastatin 20 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 75 years of age at the time of the study with high cholesterol Can have diabetes mellitus but is not currently on lipid lowering therapy Have a stable weight for >6 weeks Exclusion Criteria: Has significant cardiovascular (heart), renal (kidney), neurologic (nervous system), respiratory (lung), hepatic (liver) or metabolic disease history of mental instability or drug/alcohol abuse within the past 5 years Pregnant or nursing; human immunodeficiency virus (HIV) positive; history of cancer within the past 5 years or participation in an investigational trial within the last 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-6213 160 mg + Atorvastatin 20 mg<br>1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks | Drug: MK-6213<br>* MK-6213 160 mg for 4 weeks.<br>Drug: Atorvastatin calcium<br>* atorvastatin calcium 20mg for 4 weeks.<br>* Other names: LIPITOR ®;|
| Active Comparator: Atorvastatin 20 mg<br>1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks | Drug: Atorvastatin calcium<br>* atorvastatin calcium 20mg for 4 weeks.<br>* Other names: LIPITOR ®;Drug: Placebo for MK-6312 160 mg<br> <br> |
| Experimental: MK-6213 160 mg<br>1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks | Drug: MK-6213<br>* MK-6213 160 mg for 4 weeks.<br>Drug: Placebo for Atorvastatin 20 mg<br> <br> |
| Placebo Comparator: Placebo<br>1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks | Drug: Placebo for MK-6312 160 mg<br> <br> Drug: Placebo for Atorvastatin 20 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (predose) and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | Baseline (predose) and Week 4 | 
| Percentage Change From Baseline in Apolipoprotein B (ApoB) | 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. | 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. | 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. | 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. | Baseline (predose) and Week 4 |