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A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: rosuvastatin 5 mg + ezetimibe 10 mg
Comparator: rosuvastatin 10 mg
Comparator: rosuvastatin 10 mg + ezetimibe 10 mg
Comparator: rosuvastatin 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:

  • Participant is currently taking a stable dose of lipid lowering agent(s). (if applicable) or is statin naive
  • Participant is currently taking a stable dose of lipid lowering agent(s). (if is at least moderate high risk for Coronary Heart Disease (CHD))
  • Participant is currently taking a stable dose of lipid lowering agent(s). (if is willing to maintain Therapeutic Lifestyle Changes (TLC) / American Diabetes Association(ADA) diet)

Exclusion Criteria:

  • Participant weighs less than 100 lbs (45 kg).
  • Participant has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any components of these medications.
  • If female, participant is pregnant or breastfeeding.
  • Participant consumes more than 2 alcoholic beverages per day.
  • Participant has been in a clinical trial within the last 30 days.
  • Participant has heart problems such as CHF, unstable angina or heart attack.
  • Participant has type 1 or 2 diabetes and has changed their medication in the last 2 months.
  • Participant has liver disease.
  • Participant is Human Immunodeficiency Virus (HIV) positive.
  • Participant has a history of drug or alcohol abuse in the last year.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Rosuvastatin 5 mg + Ezetimibe 10 mg

    Rosuvastatin 10 mg

    Rosuvastatin 10 mg + Ezetimibe 10 mg

    Rosuvastatin 20 mg

    Arm Description

    Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.

    Participants who received rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.

    Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.

    Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment
    The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.

    Secondary Outcome Measures

    Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum
    The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
    Number of Participants Who Reached Their Target LDL-C Level
    Participants were analyzed to evaluate the LDL-C (<100 mg/dL for moderately high risk patients and high risk patients without AVD and <70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment.
    Number of Participants in Each Stratum Who Reached Their Target LDL-C Level
    Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks.
    Number of Participants Who Reached the LDL-C Level of <70 mg/dl
    Participants across all strata who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
    Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl
    Participants in stratum I and in stratum II who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg).
    Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels
    Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment.

    Full Information

    First Posted
    October 30, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00783263
    Brief Title
    A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)
    Official Title
    A Multicenter, Randomized, Double-Blind, Titration Study to Evaluate the Efficacy and Safety of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia at Risk for Coronary Heart Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    May 2010 (Actual)
    Study Completion Date
    May 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
    A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal

    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
    440 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rosuvastatin 5 mg + Ezetimibe 10 mg
    Arm Type
    Experimental
    Arm Description
    Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
    Arm Title
    Rosuvastatin 10 mg
    Arm Type
    Active Comparator
    Arm Description
    Participants who received rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
    Arm Title
    Rosuvastatin 10 mg + Ezetimibe 10 mg
    Arm Type
    Experimental
    Arm Description
    Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
    Arm Title
    Rosuvastatin 20 mg
    Arm Type
    Active Comparator
    Arm Description
    Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: rosuvastatin 5 mg + ezetimibe 10 mg
    Other Intervention Name(s)
    Crestor, Zetia
    Intervention Description
    Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: rosuvastatin 10 mg
    Other Intervention Name(s)
    Crestor
    Intervention Description
    Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: rosuvastatin 10 mg + ezetimibe 10 mg
    Other Intervention Name(s)
    Crestor, Zetia
    Intervention Description
    Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: rosuvastatin 20 mg
    Other Intervention Name(s)
    Crestor
    Intervention Description
    Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment
    Description
    The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
    Time Frame
    Baseline to 6 weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum
    Description
    The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
    Time Frame
    Baseline to 6 weeks
    Title
    Number of Participants Who Reached Their Target LDL-C Level
    Description
    Participants were analyzed to evaluate the LDL-C (<100 mg/dL for moderately high risk patients and high risk patients without AVD and <70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment.
    Time Frame
    6 weeks of treatment
    Title
    Number of Participants in Each Stratum Who Reached Their Target LDL-C Level
    Description
    Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks.
    Time Frame
    6 weeks of treatment
    Title
    Number of Participants Who Reached the LDL-C Level of <70 mg/dl
    Description
    Participants across all strata who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
    Time Frame
    6 weeks of treatment
    Title
    Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl
    Description
    Participants in stratum I and in stratum II who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg).
    Time Frame
    6 weeks of treatment
    Title
    Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels
    Description
    Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment.
    Time Frame
    Baseline to 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: Participant is currently taking a stable dose of lipid lowering agent(s). (if applicable) or is statin naive Participant is currently taking a stable dose of lipid lowering agent(s). (if is at least moderate high risk for Coronary Heart Disease (CHD)) Participant is currently taking a stable dose of lipid lowering agent(s). (if is willing to maintain Therapeutic Lifestyle Changes (TLC) / American Diabetes Association(ADA) diet) Exclusion Criteria: Participant weighs less than 100 lbs (45 kg). Participant has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any components of these medications. If female, participant is pregnant or breastfeeding. Participant consumes more than 2 alcoholic beverages per day. Participant has been in a clinical trial within the last 30 days. Participant has heart problems such as CHF, unstable angina or heart attack. Participant has type 1 or 2 diabetes and has changed their medication in the last 2 months. Participant has liver disease. Participant is Human Immunodeficiency Virus (HIV) positive. Participant has a history of drug or alcohol abuse in the last year.
    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
    21596364
    Citation
    Bays HE, Davidson MH, Massaad R, Flaim D, Lowe RS, Tershakovec AM, Jones-Burton C. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). Am J Cardiol. 2011 Aug 15;108(4):523-30. doi: 10.1016/j.amjcard.2011.03.079. Epub 2011 May 17.
    Results Reference
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    A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)

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