<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01666704</url>
  </required_header>
  <id_info>
    <org_study_id>MB121-010</org_study_id>
    <nct_id>NCT01666704</nct_id>
  </id_info>
  <brief_title>Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis</brief_title>
  <official_title>A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Effects of BMS-823778 on Atherosclerotic Plaque Inflammation as Measured by Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET) in Patients With Atherosclerotic Cardiovascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic&#xD;
      plaque inflammation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">May 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of BMS-823778 versus placebo on carotids and/or ascending aortic will be measured by fluorodeoxyglucose (FDG) uptake in the index vessel as by positron emission tomography (PET) imaging</measure>
    <time_frame>Day 168</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices)</measure>
    <time_frame>Day 364</time_frame>
    <description>Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices): total vessel area, wall area, wall thickness, and wall area/total vessel area ratio (normalized wall index), based on the average of the right and left carotids, measured by Magnetic Resonance Imaging (MRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores</measure>
    <time_frame>Approximately up to 60 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Atherosclerotic Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Treatment A: BMS-823778 (2mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B: BMS-823778 (15mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-823778</intervention_name>
    <description>Capsules, Oral, 2mg, Once daily, 1 year</description>
    <arm_group_label>Treatment A: BMS-823778 (2mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-823778</intervention_name>
    <description>Capsules, Oral, 15mg, Once daily, 1 year</description>
    <arm_group_label>Treatment B: BMS-823778 (15mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo matching with BMS-823778</intervention_name>
    <description>Capsules, Oral, 0mg, Once daily, 1 year</description>
    <arm_group_label>Treatment C: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular&#xD;
             event&#xD;
&#xD;
          -  On stable statin dose&#xD;
&#xD;
          -  Clinically stable at time of screening and randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women of child bearing potential&#xD;
&#xD;
          -  Medical conditions that would impact the absorption of the study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <link>
    <url>http://www.bms.com/studyconnect/Pages/home.aspx</url>
    <description>BMS clinical trial educational resource</description>
  </link>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>June 19, 2013</last_update_submitted>
  <last_update_submitted_qc>June 19, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 21, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01666704
org study id: MB121-010
nct id: NCT01666704
lead sponsor: 
has dmc: No
The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic
      plaque inflammation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The effect of BMS-823778 versus placebo on carotids and/or ascending aortic will be measured by fluorodeoxyglucose (FDG) uptake in the index vessel as by positron emission tomography (PET) imaging
time frame: Day 168
measure: Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices)
time frame: Day 364
description: Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices): total vessel area, wall area, wall thickness, and wall area/total vessel area ratio (normalized wall index), based on the average of the right and left carotids, measured by Magnetic Resonance Imaging (MRI)
measure: Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores
time frame: Approximately up to 60 weeks
arm group label: Treatment A: BMS-823778 (2mg)
arm group type: Experimental
arm group label: Treatment B: BMS-823778 (15mg)
arm group type: Experimental
arm group label: Treatment C: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BMS-823778
description: Capsules, Oral, 2mg, Once daily, 1 year
arm group label: Treatment A: BMS-823778 (2mg)
intervention type: Drug
intervention name: BMS-823778
description: Capsules, Oral, 15mg, Once daily, 1 year
arm group label: Treatment B: BMS-823778 (15mg)
intervention type: Drug
intervention name: Placebo matching with BMS-823778
description: Capsules, Oral, 0mg, Once daily, 1 year
arm group label: Treatment C: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
url: http://www.bms.com/studyconnect/Pages/home.aspx
description: BMS clinical trial educational resource
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Atherosclerosis