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Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients (0653A-093)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
simvastatin (+) ezetimibe
atorvastatin
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of hypercholesterolemia Drug naive or statin treated but inadequately controlled patients against NCEP ATP III guideline goal Exclusion Criteria: Hypersensitivity to HMG-CoA inhibitor or Ezetimibe

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    1. simvastatin/ezetimibe 10/20mg

    2. atorvastatin 10mg

    Outcomes

    Primary Outcome Measures

    LDL-C lowering efficacy

    Secondary Outcome Measures

    Safety

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    February 4, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00157924
    Brief Title
    Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients (0653A-093)
    Official Title
    A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Hypercholesterolemic Patients With Diabetes Mellitus or Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in Korea.

    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 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    190 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    1. simvastatin/ezetimibe 10/20mg
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    2. atorvastatin 10mg
    Intervention Type
    Drug
    Intervention Name(s)
    simvastatin (+) ezetimibe
    Other Intervention Name(s)
    MK0653A, Vytorin®
    Intervention Description
    simvastatin (+) ezetimibe 10/20mg.
    Intervention Type
    Drug
    Intervention Name(s)
    atorvastatin
    Other Intervention Name(s)
    Lipitor®
    Intervention Description
    atorvastatin 10mg
    Primary Outcome Measure Information:
    Title
    LDL-C lowering efficacy
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Safety
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of hypercholesterolemia Drug naive or statin treated but inadequately controlled patients against NCEP ATP III guideline goal Exclusion Criteria: Hypersensitivity to HMG-CoA inhibitor or Ezetimibe
    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
    Links:
    URL
    http://www.merck.com/clinical-trials/policies-perspectives.html
    Description
    Click here to access a synopsis of the study results.
    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

    Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients (0653A-093)

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