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To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: atorvastatin
Comparator: Placebo
Comparator: ezetimibe
Comparator: Placebo.
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: Patient with LDL-C >100 mg/dL & on a stable dose of atorvastatin 20 mg Exclusion Criteria: Pregnant or lactating women or intending to become pregnant Patient with sensitivity or intolerance to ezetimibe or atorvastatin Patient with diabetes or coronary heart disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    1

    2

    Arm Description

    Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).

    Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6
    [(6 week value - baseline value)/baseline value]*100%.

    Secondary Outcome Measures

    Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6
    [(6 week value - baseline value)/baseline value]*100%.
    Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
    [(6 week value - baseline value)/baseline value]*100%.
    Percent Change From Baseline in Total-Cholesterol at Week 6
    ([6 week value - baseline value)/baseline value]*100%.
    Percent Change From Baseline in Triglycerides (TG) at Week 6
    [(6 week value - baseline value)/baseline value]*100%.
    Percent Change From Baseline in Apolipoprotein B at Week 6
    [(6 week value - baseline value)/baseline value]*100%.
    Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
    [(6 week value - baseline value)/baseline value]*100%.
    Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
    [(6 week value - baseline value)/baseline value]*100%.
    Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6
    [(6 week value - baseline value)/baseline value]*100%.
    Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
    [(6 week value - baseline value)/baseline value]*100%.
    Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6
    [(6 week value - baseline value)/baseline value]*100%.
    Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6

    Full Information

    First Posted
    January 10, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00276458
    Brief Title
    To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)
    Official Title
    A Multicenter., Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 Mg
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    January 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
    The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.

    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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    196 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: atorvastatin
    Intervention Description
    Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: ezetimibe
    Intervention Description
    Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo.
    Intervention Description
    Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6
    Description
    [(6 week value - baseline value)/baseline value]*100%.
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6
    Description
    [(6 week value - baseline value)/baseline value]*100%.
    Time Frame
    6 weeks
    Title
    Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
    Description
    [(6 week value - baseline value)/baseline value]*100%.
    Time Frame
    6 Weeks
    Title
    Percent Change From Baseline in Total-Cholesterol at Week 6
    Description
    ([6 week value - baseline value)/baseline value]*100%.
    Time Frame
    6 Weeks
    Title
    Percent Change From Baseline in Triglycerides (TG) at Week 6
    Description
    [(6 week value - baseline value)/baseline value]*100%.
    Time Frame
    6 weeks
    Title
    Percent Change From Baseline in Apolipoprotein B at Week 6
    Description
    [(6 week value - baseline value)/baseline value]*100%.
    Time Frame
    6 Weeks
    Title
    Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
    Description
    [(6 week value - baseline value)/baseline value]*100%.
    Time Frame
    6 Weeks
    Title
    Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
    Description
    [(6 week value - baseline value)/baseline value]*100%.
    Time Frame
    6 Weeks
    Title
    Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6
    Description
    [(6 week value - baseline value)/baseline value]*100%.
    Time Frame
    6 Weeks
    Title
    Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
    Description
    [(6 week value - baseline value)/baseline value]*100%.
    Time Frame
    6 Weeks
    Title
    Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6
    Description
    [(6 week value - baseline value)/baseline value]*100%.
    Time Frame
    6 Weeks
    Title
    Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6
    Time Frame
    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: Patient with LDL-C >100 mg/dL & on a stable dose of atorvastatin 20 mg Exclusion Criteria: Pregnant or lactating women or intending to become pregnant Patient with sensitivity or intolerance to ezetimibe or atorvastatin Patient with diabetes or coronary heart disease
    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
    19026302
    Citation
    Conard SE, Bays HE, Leiter LA, Bird SR, Rubino J, Lowe RS, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1489-94. doi: 10.1016/j.amjcard.2008.09.075. Epub 2008 Oct 23.
    Results Reference
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    To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)

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