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A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)

Primary Purpose

Coronary Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0653, ezetimibe / Duration of Treatment: 27 Weeks
MK0733, simvastatin / Duration of Treatment: 27 Weeks
Comparator: simvastatin / Duration of Treatment: 27 Weeks
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women aged 18 to 80 at risk for Heart Disease who have LDL-C levels greater than or equal to 130 mg/dL and triglyceride level less than or equal to 350 mg/dL
  • Patients must be able to maintain the National Cholesterol Education Program diet throughout the course of the study

Exclusion Criteria:

  • Patients are excluded from the study if their weight is less than 50% of ideal body weight, if they are pregnant or lactating, have congestive heart failure, uncontrolled heart rhythm problems or a recent heart attack, coronary artery bypass surgery, or angioplasty. Additionally, patients with poorly controlled Type 1 or 2 diabetes mellitus, kidney disease, uncontrolled endocrine or metabolic disease, are known HIV positive, and uncontrolled high blood pressure

Sites / Locations

    Outcomes

    Primary Outcome Measures

    LDL-C measurement (target goal = <100 mg/dL)

    Secondary Outcome Measures

    Well tolerated in patients

    Full Information

    First Posted
    October 29, 2007
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00551447
    Brief Title
    A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)
    Official Title
    A Comparison of Treatment With Ezetimibe (SCH 58235) and Simvastatin Coadministration Versus Simvastatin in Attaining the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Coronary Heart Disease (CHD) or CHD Risk Equivalent Strata Low-Density Lipoprotein Cholesterol (LDL-c)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    March 2003 (Actual)
    Study Completion Date
    March 2003 (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 purpose of this study is to determine if the administration of ezetimibe and simvastatin together is more effective than simvastatin alone in lowering LDL-C levels to a goal of <100 mg/dL in patients at risk for Heart Disease.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0653, ezetimibe / Duration of Treatment: 27 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    MK0733, simvastatin / Duration of Treatment: 27 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: simvastatin / Duration of Treatment: 27 Weeks
    Primary Outcome Measure Information:
    Title
    LDL-C measurement (target goal = <100 mg/dL)
    Time Frame
    27 Weeks
    Secondary Outcome Measure Information:
    Title
    Well tolerated in patients
    Time Frame
    27 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men and women aged 18 to 80 at risk for Heart Disease who have LDL-C levels greater than or equal to 130 mg/dL and triglyceride level less than or equal to 350 mg/dL Patients must be able to maintain the National Cholesterol Education Program diet throughout the course of the study Exclusion Criteria: Patients are excluded from the study if their weight is less than 50% of ideal body weight, if they are pregnant or lactating, have congestive heart failure, uncontrolled heart rhythm problems or a recent heart attack, coronary artery bypass surgery, or angioplasty. Additionally, patients with poorly controlled Type 1 or 2 diabetes mellitus, kidney disease, uncontrolled endocrine or metabolic disease, are known HIV positive, and uncontrolled high blood pressure
    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

    Citations:
    PubMed Identifier
    16369229
    Citation
    McKenney J, Ballantyne CM, Feldman TA, Brady WE, Shah A, Davies MJ, Palmisano J, Mitchel YB. LDL-C goal attainment with ezetimibe plus simvastatin coadministration vs atorvastatin or simvastatin monotherapy in patients at high risk of CHD. MedGenMed. 2005 Jul 14;7(3):3.
    Results Reference
    background
    PubMed Identifier
    15194017
    Citation
    Feldman T, Koren M, Insull W Jr, McKenney J, Schrott H, Lewin A, Shah S, Sidisin M, Cho M, Kush D, Mitchel Y. Treatment of high-risk patients with ezetimibe plus simvastatin co-administration versus simvastatin alone to attain National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol goals. Am J Cardiol. 2004 Jun 15;93(12):1481-6. doi: 10.1016/j.amjcard.2004.02.059.
    Results Reference
    background
    PubMed Identifier
    16004682
    Citation
    Catapano A, Brady WE, King TR, Palmisano J. Lipid altering-efficacy of ezetimibe co-administered with simvastatin compared with rosuvastatin: a meta-analysis of pooled data from 14 clinical trials. Curr Med Res Opin. 2005 Jul;21(7):1123-30. doi: 10.1185/030079905X50642.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)

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