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Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ezetimibe/simvastatin 10/40
atorvastatin 40 mg
atorvastatin 20 mg
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:

  • Participants who are either statin naive or on approved lipid lowering therapy for 6 weeks prior to study initiation
  • Participant meets Adult Treatment Panel (ATP) III High Risk criteria

Exclusion Criteria:

  • Females who are pregnant or breastfeeding
  • Participant consumes more than 14 alcoholic beverages per week
  • Participant has been treated with an investigational drug within the last 30 days
  • Participant has congestive heart failure (New York Heart Association [NYHA] Type III or IV)
  • Participant has had gastric bypass
  • Participant is newly diagnosed with type 1 or 2 diabetes
  • Participant is Human Immunodeficiency Virus (HIV) positive
  • Participant has a history of drug or alcohol abuse within the last 5 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ezetimibe/simvastatin 10/40

    atorvastatin 40 mg

    Arm Description

    Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period

    Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Number of Participants Reaching LDL-C Target Goals of <70 mg/dL
    Target LDL-C level of < 70 mg/dL (1.81 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.
    Number of Participants Reaching LDL-C Target Goal <77 mg/dL
    Target LDL-C level of < 77 mg/dL (2.00 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.
    Number of Participants Reaching LDL-C Target Goal <100 mg/dL
    Target LDL-C level of < 100 mg/dL (2.59 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.
    Percent Change From Baseline in Total Cholesterol
    Percent Change From Baseline in Triglycerides
    Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol
    Percent Change From Baseline in Non-HDL Cholesterol
    Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio
    Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio
    Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio
    Percent Change From Baseline in Apolipoprotein B
    Percent Change From Baseline in Apolipoprotein A-1
    Percent Change From Baseline in Apolipoprotein B/A-1 Ratio
    Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)

    Full Information

    First Posted
    October 29, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00782184
    Brief Title
    Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
    Official Title
    A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus Doubling the Baseline Dose of Atorvastatin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    September 2010 (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
    Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.

    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
    250 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ezetimibe/simvastatin 10/40
    Arm Type
    Experimental
    Arm Description
    Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period
    Arm Title
    atorvastatin 40 mg
    Arm Type
    Active Comparator
    Arm Description
    Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period
    Intervention Type
    Drug
    Intervention Name(s)
    ezetimibe/simvastatin 10/40
    Other Intervention Name(s)
    Vytorin
    Intervention Description
    ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    atorvastatin 40 mg
    Other Intervention Name(s)
    Lipitor
    Intervention Description
    atorvastatin 40 mg tablet once daily for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    atorvastatin 20 mg
    Other Intervention Name(s)
    Lipitor
    Intervention Description
    All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Low Density Lipoprotein (LDL)-C
    Time Frame
    Baseline (Treatment Day 1), Treatment Week 6
    Secondary Outcome Measure Information:
    Title
    Number of Participants Reaching LDL-C Target Goals of <70 mg/dL
    Description
    Target LDL-C level of < 70 mg/dL (1.81 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.
    Time Frame
    Treatment Week 6
    Title
    Number of Participants Reaching LDL-C Target Goal <77 mg/dL
    Description
    Target LDL-C level of < 77 mg/dL (2.00 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.
    Time Frame
    Treatment Week 6
    Title
    Number of Participants Reaching LDL-C Target Goal <100 mg/dL
    Description
    Target LDL-C level of < 100 mg/dL (2.59 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.
    Time Frame
    Treatment Week 6
    Title
    Percent Change From Baseline in Total Cholesterol
    Time Frame
    Baseline (Treatment Day 1), Treatment Week 6
    Title
    Percent Change From Baseline in Triglycerides
    Time Frame
    Baseline (Treatment Day 1), Treatment Week 6
    Title
    Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol
    Time Frame
    Baseline (Treatment Day 1), Treatment Week 6
    Title
    Percent Change From Baseline in Non-HDL Cholesterol
    Time Frame
    Baseline (Treatment Day 1), Treatment Week 6
    Title
    Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio
    Time Frame
    Baseline (Treatment Day 1), Treatment Week 6
    Title
    Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio
    Time Frame
    Baseline (Treatment Day 1), Treatment Week 6
    Title
    Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio
    Time Frame
    Baseline (Treatment Day 1), Treatment Week 6
    Title
    Percent Change From Baseline in Apolipoprotein B
    Time Frame
    Baseline (Treatment Day 1), Treatment Week 6
    Title
    Percent Change From Baseline in Apolipoprotein A-1
    Time Frame
    Baseline (Treatment Day 1), Treatment Week 6
    Title
    Percent Change From Baseline in Apolipoprotein B/A-1 Ratio
    Time Frame
    Baseline (Treatment Day 1), Treatment Week 6
    Title
    Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
    Time Frame
    Baseline (Treatment Day 1), Treatment Week 6

    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: Participants who are either statin naive or on approved lipid lowering therapy for 6 weeks prior to study initiation Participant meets Adult Treatment Panel (ATP) III High Risk criteria Exclusion Criteria: Females who are pregnant or breastfeeding Participant consumes more than 14 alcoholic beverages per week Participant has been treated with an investigational drug within the last 30 days Participant has congestive heart failure (New York Heart Association [NYHA] Type III or IV) Participant has had gastric bypass Participant is newly diagnosed with type 1 or 2 diabetes Participant is Human Immunodeficiency Virus (HIV) positive Participant has a history of drug or alcohol abuse within the last 5 years
    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
    22293030
    Citation
    Hing Ling PK, Civeira F, Dan AG, Hanson ME, Massaad R, De Tilleghem Cle B, Milardo C, Triscari J. Ezetimibe/simvastatin 10/40 mg versus atorvastatin 40 mg in high cardiovascular risk patients with primary hypercholesterolemia: a randomized, double-blind, active-controlled, multicenter study. Lipids Health Dis. 2012 Jan 31;11:18. doi: 10.1186/1476-511X-11-18.
    Results Reference
    derived

    Learn more about this trial

    Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)

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