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To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
atorvastatin
atorvastatin
ezetimibe
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 >70 mg/dL & on a stable dose of atorvastatin 40 mg Exclusion Criteria: Pregnant or lactating women or intending to become pregnant Patient with sensitivity or intolerance to ezetimibe or atorvastatin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    1

    2

    Arm Description

    Atorvastatin 80 mg

    Atorvastatin 40 mg + ezetimibe 10 mg

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)
    Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100%
    Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
    Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100%
    Percent Change From Baseline to Week 6 in Total-Cholesterol
    Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100%
    Percent Change From Baseline to Week 6 in Triglycerides (TG)
    Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100%
    Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)
    Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100%
    Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)
    Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100%
    Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio
    Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
    Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio
    Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
    Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio
    Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
    Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio
    Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
    Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)
    Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100%
    Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6

    Full Information

    First Posted
    January 11, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00276484
    Brief Title
    To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)
    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 High Risk for CHD Not Adequately Controlled on Atorvastatin 40 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
    February 2008 (Actual)
    Study Completion Date
    March 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
    To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 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
    579 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Atorvastatin 80 mg
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Atorvastatin 40 mg + ezetimibe 10 mg
    Intervention Type
    Drug
    Intervention Name(s)
    atorvastatin
    Intervention Description
    Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    atorvastatin
    Intervention Description
    Atorvastatin 40 mg by mouth, once a day for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    ezetimibe
    Intervention Description
    Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks.
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C
    Description
    Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100%
    Time Frame
    Baseline and 6 weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)
    Description
    Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100%
    Time Frame
    Baseline and 6 weeks
    Title
    Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
    Description
    Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100%
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline to Week 6 in Total-Cholesterol
    Description
    Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100%
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline to Week 6 in Triglycerides (TG)
    Description
    Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100%
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)
    Description
    Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100%
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)
    Description
    Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100%
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio
    Description
    Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio
    Description
    Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio
    Description
    Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio
    Description
    Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
    Time Frame
    Baseline and 6 Weeks
    Title
    Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)
    Description
    Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100%
    Time Frame
    Baseline and 6 Weeks
    Title
    Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 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 >70 mg/dL & on a stable dose of atorvastatin 40 mg Exclusion Criteria: Pregnant or lactating women or intending to become pregnant Patient with sensitivity or intolerance to ezetimibe or atorvastatin
    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
    19026303
    Citation
    Leiter LA, Bays H, Conard S, Bird S, Rubino J, Hanson ME, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (40 mg) compared with uptitration of atorvastatin (to 80 mg) in hypercholesterolemic patients at high risk of coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1495-501. doi: 10.1016/j.amjcard.2008.09.076. Epub 2008 Oct 23.
    Results Reference
    background
    PubMed Identifier
    21118495
    Citation
    Bays H, Conard S, Leiter LA, Bird S, Jensen E, Hanson ME, Shah A, Tershakovec AM. Are post-treatment low-density lipoprotein subclass pattern analyses potentially misleading? Lipids Health Dis. 2010 Nov 30;9:136. doi: 10.1186/1476-511X-9-136.
    Results Reference
    derived
    PubMed Identifier
    20151997
    Citation
    Conard S, Bays H, Leiter LA, Bird S, Lin J, Hanson ME, Shah A, Tershakovec AM. Ezetimibe added to atorvastatin compared with doubling the atorvastatin dose in patients at high risk for coronary heart disease with diabetes mellitus, metabolic syndrome or neither. Diabetes Obes Metab. 2010 Mar;12(3):210-8. doi: 10.1111/j.1463-1326.2009.01152.x.
    Results Reference
    derived

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    To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)

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