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Completed

NCT Number: NCT00687271

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-6213

Drug

MK-6213 160 mg for 4 weeks.

Atorvastatin calcium

Drug

atorvastatin calcium 20mg for 4 weeks.

Other names: atorvastatin, LIPITOR ®

Placebo for MK-6312 160 mg

Drug

Placebo for Atorvastatin 20 mg

Drug

Primary outcomes

  1. Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

    Time frame: 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 outcomes

  1. Percentage of Participants Who Experience at Least 1 Adverse Event (AE)

    Time frame: 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

  2. Percentage of Participants That Had Study Drug Discontinued Due to an AE

    Time frame: up 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.

  3. Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)

    Time frame: 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.

  4. Percentage Change From Baseline in Apolipoprotein B (ApoB)

    Time frame: 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.

  5. Percentage Change From Baseline in Total Cholesterol (TC)

    Time frame: 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.

  6. Percentage Change From Baseline in HDL-C

    Time frame: Baseline (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.

  7. Percentage Change From Baseline in TG

    Time frame: Baseline (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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 30, 2008
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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