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A Study of How MK-0736 Affects Arterial Plaque (0736-006)(TERMINATED)

Primary Purpose

Peripheral Vascular Diseases

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK-0736
Comparator: placebo (unspecified)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Diseases

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with peripheral arterial disease
  • Participants must be 18 to 85 years of age
  • Females must be postmenopausal or sterile

Exclusion Criteria:

  • Participans with hepatic, HIV, endocrine, connective tissue, psychiatric disorders or uncontrolled hypertension

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    MK-0736

    Placebo

    Arm Description

    Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks

    Participants will be orally administered placebo once daily for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Cluster of Differentiation 68 (CD68)
    CD68 is a heavily glycosylated transmembrane protein resident to macrophage lysosomes, and is the standard immunohistochemical (IHC) marker for macrophages in human tissues. CD68 protein content as a measure of macrophage number is the most often reported marker in clinical studies of plaque instability. Blood samples were taken to determine the level of CD69 present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.

    Secondary Outcome Measures

    Change From Baseline in Messenger Ribonucleic Acid (mRNA)
    mRNA is a biomarker associated with the inflammatory response. Blood samples were taken to determine the level of mRNA present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.
    Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. The percentage of participants who were discontinued from the study due to an AE was summarized.

    Full Information

    First Posted
    May 14, 2008
    Last Updated
    July 20, 2018
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    FoxHollow Technologies
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00679055
    Brief Title
    A Study of How MK-0736 Affects Arterial Plaque (0736-006)(TERMINATED)
    Official Title
    An Exploratory Double-Blind, Placebo Controlled, Randomized, 12-Week Oral Dose Study to Evaluate the Effects of MK0736 on Atherosclerotic Disease Biomarkers in Lower Extremity Plaque Excised From Patients With Peripheral Arterial Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Lack of recruitment
    Study Start Date
    March 31, 2007 (Actual)
    Primary Completion Date
    August 26, 2008 (Actual)
    Study Completion Date
    August 26, 2008 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A 12-Week Efficacy Study in participants with Peripheral Arterial Disease. the primary hypothesis is that MK-0736 7 mg administered once daily for 12 weeks will result in a decrease in lower extremity atherosclerotic plaque macrophage content when compared to placebo (an approximate decrease of up to 30% is expected).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Vascular Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-0736
    Arm Type
    Experimental
    Arm Description
    Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will be orally administered placebo once daily for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    MK-0736
    Intervention Description
    MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo (unspecified)
    Intervention Description
    Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Cluster of Differentiation 68 (CD68)
    Description
    CD68 is a heavily glycosylated transmembrane protein resident to macrophage lysosomes, and is the standard immunohistochemical (IHC) marker for macrophages in human tissues. CD68 protein content as a measure of macrophage number is the most often reported marker in clinical studies of plaque instability. Blood samples were taken to determine the level of CD69 present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.
    Time Frame
    Baseline and Week 12
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Messenger Ribonucleic Acid (mRNA)
    Description
    mRNA is a biomarker associated with the inflammatory response. Blood samples were taken to determine the level of mRNA present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.
    Time Frame
    Baseline and Week 12
    Title
    Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)
    Description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. The percentage of participants who were discontinued from the study due to an AE was summarized.
    Time Frame
    up to 14 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants with peripheral arterial disease Participants must be 18 to 85 years of age Females must be postmenopausal or sterile Exclusion Criteria: Participans with hepatic, HIV, endocrine, connective tissue, psychiatric disorders or uncontrolled hypertension
    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
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=0736-006&kw=0736-006&tab=access

    Learn more about this trial

    A Study of How MK-0736 Affects Arterial Plaque (0736-006)(TERMINATED)

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