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Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ezetimibe (+) simvastatin
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 LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline Exclusion Criteria: Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Vytorin

    Atorvastatin

    Arm Description

    Ezetimibe 10 mg/Simvastatin 20 mg

    Atorvastatin 10 mg

    Outcomes

    Primary Outcome Measures

    LDL-C Lowering Efficacy
    LDL-C = low density lipoprotein cholesterol, measured in mg/dl.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 9, 2005
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00166504
    Brief Title
    Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)
    Official Title
    A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.

    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
    203 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vytorin
    Arm Type
    Experimental
    Arm Description
    Ezetimibe 10 mg/Simvastatin 20 mg
    Arm Title
    Atorvastatin
    Arm Type
    Active Comparator
    Arm Description
    Atorvastatin 10 mg
    Intervention Type
    Drug
    Intervention Name(s)
    ezetimibe (+) simvastatin
    Other Intervention Name(s)
    MK0653A, Vytorin®
    Intervention Description
    simvastatin/ezetimibe 10/20 mg
    Intervention Type
    Drug
    Intervention Name(s)
    atorvastatin
    Other Intervention Name(s)
    Lipitor®
    Intervention Description
    atorvastatin 10 mg
    Primary Outcome Measure Information:
    Title
    LDL-C Lowering Efficacy
    Description
    LDL-C = low density lipoprotein cholesterol, measured in mg/dl.
    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 LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline Exclusion Criteria: Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors 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

    Learn more about this trial

    Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)

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