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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK-6213
Atorvastatin calcium
Placebo for MK-6312 160 mg
Placebo for Atorvastatin 20 mg
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Placebo Comparator

    Arm Label

    MK-6213 160 mg + Atorvastatin 20 mg

    Atorvastatin 20 mg

    MK-6213 160 mg

    Placebo

    Arm Description

    1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks

    1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks

    1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    May 27, 2008
    Last Updated
    January 11, 2019
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00687271
    Brief Title
    A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 14, 2008 (Actual)
    Primary Completion Date
    January 8, 2009 (Actual)
    Study Completion Date
    January 8, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    334 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-6213 160 mg + Atorvastatin 20 mg
    Arm Type
    Experimental
    Arm Description
    1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks
    Arm Title
    Atorvastatin 20 mg
    Arm Type
    Active Comparator
    Arm Description
    1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks
    Arm Title
    MK-6213 160 mg
    Arm Type
    Experimental
    Arm Description
    1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    MK-6213
    Intervention Description
    MK-6213 160 mg for 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin calcium
    Other Intervention Name(s)
    atorvastatin, LIPITOR ®
    Intervention Description
    atorvastatin calcium 20mg for 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for MK-6312 160 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for Atorvastatin 20 mg
    Primary Outcome Measure Information:
    Title
    Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
    Description
    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)
    Title
    Percentage of Participants That Had Study Drug Discontinued Due to an AE
    Description
    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
    Title
    Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
    Description
    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
    Title
    Percentage Change From Baseline in Apolipoprotein B (ApoB)
    Description
    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
    Title
    Percentage Change From Baseline in Total Cholesterol (TC)
    Description
    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
    Title
    Percentage Change From Baseline in HDL-C
    Description
    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
    Title
    Percentage Change From Baseline in TG
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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