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Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)

Primary Purpose

Hypercholesterolemia, Atherosclerosis

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ezetimibe
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >=18 years of age and treated with simvastatin 10 mg or 20 mg for at least 6 weeks and LDL-C levels of > 2.5 mmol/L to <=4.20 mmol/L (97 mg/dL to 160 mg/dL) at Visit 1.
  • history of coronary heart disease (type II diabetic patients > 30 years old with no CHD)
  • triglycerides <= 4.00 mmol/L drawn, and liver transaminases (ALT, AST) <=50% above the upper limit of normal at Visit 2, with no active liver disease, and/or creatine kinase (CK) <=50% above the upper limit of normal

Exclusion Criteria:

  • subjects with Body Mass Index >=35 kg/sqm at Visit 1
  • alcohol consumption > 14 drinks per week
  • pregnant or lactating
  • treated with any other investigational drug within 30 days prior Visit 1
  • previously treated with ezetimibe or participated in a clinical study with ezetimibe
  • any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Ezetimibe

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of patients reaching LDL-C goal of < 2.5 mmol/L (97 mg/dL) at endpoint.

    Secondary Outcome Measures

    Percent change from baseline to endpoint in LDL-C.
    Percent change from baseline to endpoint in total cholesterol (TC) triglycerides, HDL-C, non-HDL-C, LDL-C/HDL-C ratio, TC/HDL-C ratio, and apolipoprotein B.
    Safety/tolerability: adverse events, laboratory test results, vital signs.

    Full Information

    First Posted
    March 31, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
    Collaborators
    Merck Frosst Canada Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00651014
    Brief Title
    Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10mg or 20mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease and/or Type II Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Terminated
    Why Stopped
    slow subject recruitment and lack of medical and scientific merit due to change in new standard of therapy during that same period.
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co
    Collaborators
    Merck Frosst Canada Ltd.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study was designed to assess whether 6 weeks of co-administration of ezetimibe and simvastatin is more effective than simvastatin monotherapy in allowing patients in the CHD risk strata of the NCEP III guidelines to achieve their LDL-C target goal of <=3.0 mmol/L. As this study was to be conducted in Canada, the target LDL-C goal for patients with CHD, or type II diabetic patients >30 years old with no CHD, was <2.5 mmol/L.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia, Atherosclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ezetimibe
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Ezetimibe
    Other Intervention Name(s)
    SCH 58235, Zetia
    Intervention Description
    oral tablet; ezetimibe 10 mg once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    oral tablet; ezetimibe placebo once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)
    Primary Outcome Measure Information:
    Title
    Percentage of patients reaching LDL-C goal of < 2.5 mmol/L (97 mg/dL) at endpoint.
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Percent change from baseline to endpoint in LDL-C.
    Time Frame
    6 weeks
    Title
    Percent change from baseline to endpoint in total cholesterol (TC) triglycerides, HDL-C, non-HDL-C, LDL-C/HDL-C ratio, TC/HDL-C ratio, and apolipoprotein B.
    Time Frame
    6 weeks
    Title
    Safety/tolerability: adverse events, laboratory test results, vital signs.
    Time Frame
    Throughout study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: >=18 years of age and treated with simvastatin 10 mg or 20 mg for at least 6 weeks and LDL-C levels of > 2.5 mmol/L to <=4.20 mmol/L (97 mg/dL to 160 mg/dL) at Visit 1. history of coronary heart disease (type II diabetic patients > 30 years old with no CHD) triglycerides <= 4.00 mmol/L drawn, and liver transaminases (ALT, AST) <=50% above the upper limit of normal at Visit 2, with no active liver disease, and/or creatine kinase (CK) <=50% above the upper limit of normal Exclusion Criteria: subjects with Body Mass Index >=35 kg/sqm at Visit 1 alcohol consumption > 14 drinks per week pregnant or lactating treated with any other investigational drug within 30 days prior Visit 1 previously treated with ezetimibe or participated in a clinical study with ezetimibe any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study

    12. IPD Sharing Statement

    Learn more about this trial

    Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)

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