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Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED) (ACHIEVE)

Primary Purpose

Hypercholesterolemia, Familial

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: niacin (+) laropiprant (MK0524A)
Comparator: placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia, Familial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who are 18 to 70 years of age with Heterozygous Familial Hypercholesterolemia and a LDL-C greater than or equal to 100mg/dL and triglycerides less than or equal to 400mg/dL at Visit 1 while on a stable dose of intensive LDL-C lowering therapy

Exclusion Criteria:

  • A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
  • Patients with less than 80% drug study compliance
  • Patients with chronic medical conditions known to influence serum lipids or lipoproteins or significantly affect the ultrasound acoustic window
  • Patients with unstable dose of medications
  • Pregnant or lactating women, or women intending to become pregnant are excluded
  • Patient with diabetes mellitus that is poorly controlled, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
  • Patients with the following conditions: high grade stenosis (greater than 75%) of the carotid artery, chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, episode of gout (within 1 year)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    MK0524A

    placebo

    Outcomes

    Primary Outcome Measures

    Change in Mean Carotid Intima Media Thickness
    change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.

    Secondary Outcome Measures

    Change in Lipid Profile

    Full Information

    First Posted
    October 3, 2006
    Last Updated
    September 28, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00384293
    Brief Title
    Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
    Acronym
    ACHIEVE
    Official Title
    A Worldwide, Double-Blind, Randomized, Placebo-Controlled Study of MK0524A 2g Coadministered With Intensive LDL-C Lowering Therapy Compared to Intensive LDL-C Lowering Therapy Alone on Carotid Artery Intima Media Thickening (cIMT) in Patients With Heterozygous Familial Hypercholesterolemia (heFH)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima media thickening using ultrasound compared to patients taking placebo. There will be 12 scheduled clinic visits involving review of medical history, physical exam, vital signs, laboratory testing, ultrasound imaging, and electrocardiograms.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    937 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    MK0524A
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: niacin (+) laropiprant (MK0524A)
    Other Intervention Name(s)
    MK0524A
    Intervention Description
    niacin (+) laropiprant (2 g) po qd.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo
    Intervention Description
    niacin (+) laropiprant (2 g) placebo po qd.
    Primary Outcome Measure Information:
    Title
    Change in Mean Carotid Intima Media Thickness
    Description
    change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.
    Time Frame
    after 96 weeks of postrandomization treatment
    Secondary Outcome Measure Information:
    Title
    Change in Lipid Profile
    Time Frame
    after 96 weeks of postrandomization treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who are 18 to 70 years of age with Heterozygous Familial Hypercholesterolemia and a LDL-C greater than or equal to 100mg/dL and triglycerides less than or equal to 400mg/dL at Visit 1 while on a stable dose of intensive LDL-C lowering therapy Exclusion Criteria: A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study Patients with less than 80% drug study compliance Patients with chronic medical conditions known to influence serum lipids or lipoproteins or significantly affect the ultrasound acoustic window Patients with unstable dose of medications Pregnant or lactating women, or women intending to become pregnant are excluded Patient with diabetes mellitus that is poorly controlled, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin) Patients with the following conditions: high grade stenosis (greater than 75%) of the carotid artery, chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, episode of gout (within 1 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

    Learn more about this trial

    Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)

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