search
Back to results

Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ezetimibe
simvastatin
Placebo (Unspecified)
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 - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with known Coronary Artery Disease (CAD) and primary hypercholesterolemia, who are being treated with simvastatin 20mg. Simvastatin consumption meant that subjects must be currently taking simvastatin 20mg daily, and by history have taken at least 80% of daily evening doses for the preceding 6 weeks prior to baseline visit
  • Age of at least 18 years and 75 years or less
  • Calculated LDL-C concentration of at least 2.6 and 4.1mmol/l or less using the Friedewald equation, and triglyceride of less than 3.99 mmol/l

Exclusion Criteria:

  • Congestive heart failure (defined as New York Heart Association class III or IV heart failure)
  • Uncontrolled cardiac arrhythmias
  • Acute coronary syndrome, coronary bypass surgery or coronary angioplasty within 3 months of study entry
  • History of unstable or severe peripheral artery disease within 3 months of study entry
  • Uncontrolled hypertension at study entry
  • Uncontrolled or newly diagnosed diabetes mellitus (within 3 months of study entry)
  • Uncontrolled endocrine or metabolic diseases known to influence serum lipids and lipoproteins; known impairment of renal function
  • Active or chronic hepatic and hepatobiliary disease
  • Disorders that would limit study evaluation or participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    Coadministration arm: simvastatin 20mg and ezetimibe 10mg

    Monotherapy arm: simvastatin 20mg and ezetimibe placebo

    Outcomes

    Primary Outcome Measures

    Percentage reduction of LDL-C after 6 weeks of treatment.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 31, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00652444
    Brief Title
    Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)
    Official Title
    Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    August 2004 (Actual)
    Study Completion Date
    August 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.

    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 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Coadministration arm: simvastatin 20mg and ezetimibe 10mg
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Monotherapy arm: simvastatin 20mg and ezetimibe placebo
    Intervention Type
    Drug
    Intervention Name(s)
    ezetimibe
    Other Intervention Name(s)
    Zetia®, EZETROL®, MK0653
    Intervention Description
    ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.
    Intervention Type
    Drug
    Intervention Name(s)
    simvastatin
    Other Intervention Name(s)
    Zocor®, MK0733
    Intervention Description
    simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo (Unspecified)
    Intervention Description
    Matching ezetimibe placebo
    Primary Outcome Measure Information:
    Title
    Percentage reduction of LDL-C after 6 weeks of treatment.
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with known Coronary Artery Disease (CAD) and primary hypercholesterolemia, who are being treated with simvastatin 20mg. Simvastatin consumption meant that subjects must be currently taking simvastatin 20mg daily, and by history have taken at least 80% of daily evening doses for the preceding 6 weeks prior to baseline visit Age of at least 18 years and 75 years or less Calculated LDL-C concentration of at least 2.6 and 4.1mmol/l or less using the Friedewald equation, and triglyceride of less than 3.99 mmol/l Exclusion Criteria: Congestive heart failure (defined as New York Heart Association class III or IV heart failure) Uncontrolled cardiac arrhythmias Acute coronary syndrome, coronary bypass surgery or coronary angioplasty within 3 months of study entry History of unstable or severe peripheral artery disease within 3 months of study entry Uncontrolled hypertension at study entry Uncontrolled or newly diagnosed diabetes mellitus (within 3 months of study entry) Uncontrolled endocrine or metabolic diseases known to influence serum lipids and lipoproteins; known impairment of renal function Active or chronic hepatic and hepatobiliary disease Disorders that would limit study evaluation or participation
    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

    Citations:
    PubMed Identifier
    18545068
    Citation
    Zubaid M, Shakir DK, Bazargani N, Binbrek A, Gopal R, Al-Tamimi O, Bakir S. Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. J Cardiovasc Med (Hagerstown). 2008 Jul;9(7):688-93. doi: 10.2459/JCM.0b013e3282f3a1b1.
    Results Reference
    background

    Learn more about this trial

    Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)

    We'll reach out to this number within 24 hrs