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

Phase 2
Completed
Conditions
Hypercholesterolemia
Interventions
Drug: Atorvastatin calcium
Drug: MK-6213
Drug: Placebo for Atorvastatin 20 mg
Drug: Placebo for MK-6312 160 mg
Registration Number
NCT00687271
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
334
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Atorvastatin 20 mgAtorvastatin calcium1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks
MK-6213 160 mg + Atorvastatin 20 mgAtorvastatin calcium1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks
MK-6213 160 mgPlacebo for Atorvastatin 20 mg1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks
PlaceboPlacebo for Atorvastatin 20 mg1 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
Atorvastatin 20 mgPlacebo for MK-6312 160 mg1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks
MK-6213 160 mgMK-62131 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks
PlaceboPlacebo for MK-6312 160 mg1 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
MK-6213 160 mg + Atorvastatin 20 mgMK-62131 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks
Primary Outcome Measures
NameTimeMethod
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)Baseline (predose) and Week 4

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.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants Who Experience at Least 1 Adverse Event (AE)Up to 14 days post last dose of study drug (up to 6 weeks)

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

Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)Baseline (predose) and Week 4

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.

Percentage of Participants That Had Study Drug Discontinued Due to an AEup to 4 weeks

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.

Percentage Change From Baseline in Apolipoprotein B (ApoB)Baseline (predose) and Week 4

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.

Percentage Change From Baseline in HDL-CBaseline (predose) and Week 4

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.

Percentage Change From Baseline in TGBaseline (predose) and Week 4

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.

Percentage Change From Baseline in Total Cholesterol (TC)Baseline (predose) and Week 4

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.

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