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Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

Primary Purpose

Hypercholesterolemia, Metabolic Syndrome

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ezetimibe (+) simvastatin
Comparator: atorvastatin calcium
Comparator: Placebo (unspecified)
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category

Exclusion Criteria:

  • A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
  • Patient is likely to be greater than 20% noncompliant in taking study medications
  • Patients with chronic medical conditions
  • Patients with unstable doses of medications
  • Pregnant or lactating women, women intending to become pregnant
  • Patient is currently receiving prescription therapy with statins or other lipid-altering medications
  • Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Other

    Other

    Other

    Other

    Other

    Arm Label

    1

    2

    3

    4

    5

    Arm Description

    Arm 1: drug + comparator + Placebo

    Arm 2: drug + comparator + Placebo

    Arm 3: drug + comparator + Placebo

    Arm 4: drug + comparator + Placebo

    Arm 5: drug + comparator + Placebo

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6

    Secondary Outcome Measures

    Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6
    Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6
    Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
    Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
    Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6
    Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6
    Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6
    Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6
    Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6
    Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6
    Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6
    Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)
    Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)
    Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6

    Full Information

    First Posted
    December 8, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00409773
    Brief Title
    Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
    Official Title
    A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    July 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1143 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Other
    Arm Description
    Arm 1: drug + comparator + Placebo
    Arm Title
    2
    Arm Type
    Other
    Arm Description
    Arm 2: drug + comparator + Placebo
    Arm Title
    3
    Arm Type
    Other
    Arm Description
    Arm 3: drug + comparator + Placebo
    Arm Title
    4
    Arm Type
    Other
    Arm Description
    Arm 4: drug + comparator + Placebo
    Arm Title
    5
    Arm Type
    Other
    Arm Description
    Arm 5: drug + comparator + Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    ezetimibe (+) simvastatin
    Other Intervention Name(s)
    MK0653A, Vytorin®
    Intervention Description
    Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: atorvastatin calcium
    Other Intervention Name(s)
    Lipitor ®
    Intervention Description
    Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo (unspecified)
    Intervention Description
    Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6
    Time Frame
    Baseline and 6 Weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6
    Time Frame
    Baseline and 6 weeks
    Title
    Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6
    Time Frame
    Baseline and 6 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category Exclusion Criteria: A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study Patient is likely to be greater than 20% noncompliant in taking study medications Patients with chronic medical conditions Patients with unstable doses of medications Pregnant or lactating women, women intending to become pregnant Patient is currently receiving prescription therapy with statins or other lipid-altering medications Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    26336957
    Citation
    Rosen JB, Ballantyne CM, Hsueh WA, Lin J, Shah AK, Lowe RS, Tershakovec AM. Influence of metabolic syndrome factors and insulin resistance on the efficacy of ezetimibe/simvastatin and atorvastatin in patients with metabolic syndrome and atherosclerotic coronary heart disease risk. Lipids Health Dis. 2015 Sep 4;14:103. doi: 10.1186/s12944-015-0075-5.
    Results Reference
    derived
    PubMed Identifier
    22108151
    Citation
    Robinson JG, Ballantyne CM, Hsueh W, Rosen J, Lin J, Shah A, Lowe RS, Hanson ME, Tershakovec AM. Achievement of specified low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol apolipoprotein B, and high-sensitivity C-reactive protein levels with ezetimibe/simvastatin or atorvastatin in metabolic syndrome patients with and without atherosclerotic vascular disease (from the VYMET study). J Clin Lipidol. 2011 Nov-Dec;5(6):474-82. doi: 10.1016/j.jacl.2011.06.004. Epub 2011 Jun 15.
    Results Reference
    derived

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    Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

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