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

Sponsor
Organon and Co (Industry)
Overall Status
Terminated
CT.gov ID
NCT00651014
Collaborator
Merck Frosst Canada Ltd. (Industry)
82
Enrollment
2
Arms
29
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Jun 1, 2006
Actual Study Completion Date :
Jun 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ezetimibe

Drug: Ezetimibe
oral tablet; ezetimibe 10 mg once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)
Other Names:
  • SCH 58235
  • Zetia

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    oral tablet; ezetimibe placebo once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients reaching LDL-C goal of < 2.5 mmol/L (97 mg/dL) at endpoint. [6 weeks]

    Secondary Outcome Measures

    1. Percent change from baseline to endpoint in LDL-C. [6 weeks]

    2. 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. [6 weeks]

    3. Safety/tolerability: adverse events, laboratory test results, vital signs. [Throughout study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co
    • Merck Frosst Canada Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00651014
    Other Study ID Numbers:
    • P03405
    First Posted:
    Apr 2, 2008
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Atherosclerosis
    Hypercholesterolemia
    Ezetimibe

    Study Results

    No Results Posted as of Feb 17, 2022