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A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ezetimibe (+) simvastatin
Comparator : rosuvastatin calcium
Comparator: Placebo (unspecified)
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 focused on measuring High Cholesterol

Eligibility Criteria

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

Inclusion Criteria:

  • Participant is currently taking a statin medication for the treatment of high cholesterol
  • Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl

Exclusion Criteria:

  • Women who are pregnant or nursing, or women who intend to become pregnant
  • Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Arm 1: drug

    Arm 2: active comparator

    Outcomes

    Primary Outcome Measures

    Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment
    Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.

    Secondary Outcome Measures

    The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment
    The percentage of participants who achieved a target LDL-C goal of < 100 mg/dL, of <70 mg/dL, and of <77 mg/dL at study endpoint after six weeks of treatment. The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group.

    Full Information

    First Posted
    May 24, 2007
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00479713
    Brief Title
    A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)
    Official Title
    A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary High Cholesterol and High Cardiovascular Risk Not Controlled With a Prior Statin Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2007 (Actual)
    Primary Completion Date
    March 1, 2008 (Actual)
    Study Completion Date
    March 1, 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
    This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Arm 1: drug
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Arm 2: active comparator
    Intervention Type
    Drug
    Intervention Name(s)
    ezetimibe (+) simvastatin
    Other Intervention Name(s)
    MK0653A, Vytorin®
    Intervention Description
    ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator : rosuvastatin calcium
    Intervention Description
    rosuvastatin 10mg. The treatment duration will be 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo (unspecified)
    Intervention Description
    rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo (unspecified)
    Intervention Description
    ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks.
    Primary Outcome Measure Information:
    Title
    Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment
    Description
    Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.
    Time Frame
    Baseline and 6 weeks
    Secondary Outcome Measure Information:
    Title
    The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment
    Description
    The percentage of participants who achieved a target LDL-C goal of < 100 mg/dL, of <70 mg/dL, and of <77 mg/dL at study endpoint after six weeks of treatment. The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group.
    Time Frame
    after 6 weeks of treatment
    Other Pre-specified Outcome Measures:
    Title
    Percent Change From Baseline in Total Cholesterol
    Description
    Percent change from baseline in total cholesterol at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.
    Time Frame
    Baseline and 6 weeks
    Title
    Percent Change From Baseline in Triglycerides.
    Description
    Percent change from baseline in triglycerides at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.
    Time Frame
    Baseline and 6 weeks
    Title
    Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
    Description
    Percent change from baseline in HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.
    Time Frame
    Baseline and 6 weeks
    Title
    Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C)
    Description
    Percent change from baseline in non HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.
    Time Frame
    Baseline and 6 weeks
    Title
    Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio
    Description
    Percent change from baseline in LDL-C/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.
    Time Frame
    Baseline and 6 weeks
    Title
    Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio
    Description
    Percent change from baseline in total cholesterol/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.
    Time Frame
    Baseline and 6 weeks
    Title
    Percent Change From Baseline in Apolipoprotein B
    Description
    Percent change from baseline in apolipoprotein (Apo) B at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.
    Time Frame
    Baseline and 6 weeks
    Title
    Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein
    Description
    Percent change from baseline in hs-C reactive protein at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.
    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: Participant is currently taking a statin medication for the treatment of high cholesterol Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl Exclusion Criteria: Women who are pregnant or nursing, or women who intend to become pregnant Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study
    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
    19222610
    Citation
    Farnier M, Averna M, Missault L, Vaverkova H, Viigimaa M, Massaad R, Vandormael K, Johnson-Levonas AO, Brudi P. Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study. Int J Clin Pract. 2009 Apr;63(4):547-59. doi: 10.1111/j.1742-1241.2009.02022.x. Epub 2009 Feb 16.
    Results Reference
    background
    PubMed Identifier
    21859750
    Citation
    Averna M, Missault L, Vaverkova H, Farnier M, Viigimaa M, Dong Q, Shah A, Johnson-Levonas AO, Taggart W, Brudi P. Lipid-altering efficacy of switching to ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk patients with and without metabolic syndrome. Diab Vasc Dis Res. 2011 Oct;8(4):262-70. doi: 10.1177/1479164111418136. Epub 2011 Aug 22.
    Results Reference
    derived
    PubMed Identifier
    21050476
    Citation
    Viigimaa M, Vaverkova H, Farnier M, Averna M, Missault L, Hanson ME, Dong Q, Shah A, Brudi P. Ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk hypercholesterolemic patients stratified by prior statin treatment potency. Lipids Health Dis. 2010 Nov 4;9:127. doi: 10.1186/1476-511X-9-127.
    Results Reference
    derived

    Learn more about this trial

    A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)

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