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

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

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 Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: MK-6213; Drug: Atorvastatin calcium; Drug: Placebo for MK-6312 160 mg; Drug: Placebo for Atorvastatin 20 mg

• Study Type: Interventional
• Enrollment (Actual): 334
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2008
• Primary Completion (Actual): January 8, 2009
• Study Completion (Actual): January 8, 2009

Study Registration Dates

• First Submitted: May 27, 2008
• First Submitted That Met QC Criteria: May 29, 2008
• First Posted (Estimate): May 30, 2008

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Calcium-Regulating Hormones and Agents; Atorvastatin; Calcium
• Other Study ID Numbers: 6213-006; 2007_514 (Other Identifier: Sponsor Registry Number); 2007-003684-41 (EudraCT Number); MK-6314-006 (Other Identifier: Merck Study Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No