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A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Atorvastatin 10 mg
Ezetimibe 10 mg/simvastatin 20 mg
Atorvastatin 20 mg
Ezetimibe 10 mg/simvastatin 40 mg
Atorvastatin 40 mg
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring High Cholesterol

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient has a cholesterol level of 130 mg/dL or greater
  • Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study
  • Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines

Exclusion Criteria:

  • Patient weighs less than 100 lbs
  • Patient has an allergy to ezetimibe, simvastatin or atorvastatin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    4

    5

    Arm Description

    Each patient will receive 1 active treatment dose & 2 Placebo (Pbo) doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

    Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

    Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

    Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

    Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12

    Secondary Outcome Measures

    Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12
    Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
    Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.
    Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12
    Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12
    Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.
    Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
    Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.

    Full Information

    First Posted
    September 25, 2007
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
    Collaborators
    Merck Shering-Plough JV Study
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00535405
    Brief Title
    A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
    Official Title
    A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2007 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co
    Collaborators
    Merck Shering-Plough JV Study

    4. Oversight

    5. Study Description

    Brief Summary
    A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia
    Keywords
    High Cholesterol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1289 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Each patient will receive 1 active treatment dose & 2 Placebo (Pbo) doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
    Arm Title
    5
    Arm Type
    Experimental
    Arm Description
    Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin 10 mg
    Intervention Description
    Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ezetimibe 10 mg/simvastatin 20 mg
    Intervention Description
    Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin 20 mg
    Intervention Description
    Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ezetimibe 10 mg/simvastatin 40 mg
    Intervention Description
    Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin 40 mg
    Intervention Description
    Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
    Time Frame
    Baseline and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12
    Time Frame
    12 weeks
    Title
    Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
    Description
    Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.
    Time Frame
    12 Weeks
    Title
    Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12
    Time Frame
    12 Weeks
    Title
    Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12
    Description
    Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.
    Time Frame
    12 Weeks
    Title
    Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
    Description
    Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.
    Time Frame
    12 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient has a cholesterol level of 130 mg/dL or greater Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines Exclusion Criteria: Patient weighs less than 100 lbs Patient has an allergy to ezetimibe, simvastatin 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
    21029821
    Citation
    Foody JM, Brown WV, Zieve F, Adewale AJ, Flaim D, Lowe RS, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults >/=65 years of age with hypercholesterolemia and with or at moderately high/high risk for coronary heart disease (the VYTELD study). Am J Cardiol. 2010 Nov 1;106(9):1255-63. doi: 10.1016/j.amjcard.2010.06.051.
    Results Reference
    result

    Learn more about this trial

    A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

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