<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/NCT01707394</url>
  </required_header>
  <id_info>
    <org_study_id>CV185-118</org_study_id>
    <secondary_id>2012-001581-15</secondary_id>
    <nct_id>NCT01707394</nct_id>
  </id_info>
  <brief_title>Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder</brief_title>
  <official_title>Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of&#xD;
      this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for&#xD;
      thrombosis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2013</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban</measure>
    <time_frame>Up to 26 hours, post dose (from Day 1 to Day 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum estimated plasma concentration (Cmax) of Apixaban</measure>
    <time_frame>Up to 26 hours, post dose (from Day 1 to Day 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban</measure>
    <time_frame>Up to 26 hours, post dose (from Day 1 to Day 2)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Adverse Events (AEs)</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Vital Signs of body temperature</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Vital Signs of respiratory rate</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Vital Signs of blood pressure</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Vital Signs of heart rate</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormalities in Physical Examinations</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Clinical Laboratory Tests of blood</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Clinical Laboratory Tests of blood serum</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in International Normalized Ratio (INR) clotting activity during treatment</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Prothrombin Time (PT) clotting activity during treatment</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Clinical Laboratory Tests of urine</measure>
    <time_frame>Up to 30 Days after last dosing</time_frame>
    <description>Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics will be analyzed using anti-Factor Xa activity</measure>
    <time_frame>Up to 26 hours, post dose (from Day 1 to Day 2)</time_frame>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Thromboembolism</condition>
  <arm_group>
    <arm_group_label>Group 1: Apixaban (low dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2A: Apixaban (low dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2B: Apixaban (low dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: Apixaban (low dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: Apixaban (low dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5: Apixaban (low dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2A (higher dose): Apixaban (low dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Group 1: Apixaban (low dose)</arm_group_label>
    <arm_group_label>Group 2A (higher dose): Apixaban (low dose)</arm_group_label>
    <arm_group_label>Group 2A: Apixaban (low dose)</arm_group_label>
    <arm_group_label>Group 2B: Apixaban (low dose)</arm_group_label>
    <arm_group_label>Group 3: Apixaban (low dose)</arm_group_label>
    <arm_group_label>Group 4: Apixaban (low dose)</arm_group_label>
    <arm_group_label>Group 5: Apixaban (low dose)</arm_group_label>
    <other_name>BMS-562247</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For more information regarding BMS clinical trial participation, please visit&#xD;
        www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with any stable disease that are at risk for a venous or arterial&#xD;
             thrombotic disorder&#xD;
&#xD;
          -  Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected&#xD;
             gestational age) to &lt;18 years of age&#xD;
&#xD;
               -  Gestational and post-conceptual age will only be taken into consideration for&#xD;
                  eligibility up to 6 months of age&#xD;
&#xD;
               -  Neonates: defined as newly born (within 4 weeks)&#xD;
&#xD;
          -  Participants with any functional CVAD (Central Venous Access Device) in the upper or&#xD;
             lower venous system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or recent (within 3 months of study drug administration) gastrointestinal&#xD;
             disease or gastrointestinal surgery that, in the opinion of the investigator and the&#xD;
             BMS Medical Monitor, could impact the absorption of the study drug&#xD;
&#xD;
          -  Active bleeding or high risk of bleeding&#xD;
&#xD;
          -  Inability to tolerate oral medication or administration of oral medication via an&#xD;
             enteral tube (nasogastric tube [NG tube] or gastronomy tube [G-tube])&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>18 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>
  <location>
    <facility>
      <name>Arkansas Children'S Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202-3591</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children'S Hospital Of Orange County</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connecticut Children's Medical Center</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare Of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blank Childrens Hospital</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kosair Charities Pediatric Clinical Research Unit</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children'S Mercy Hospital And Clinics</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Peter'S University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProMedica Toledo Children's Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Hershey Children'S Hospital</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital Of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hopsital Of Pittsburgh Of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Of Pittsburgh Of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital Of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta - Edmonton Clinic Health Academy</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1C9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital For Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <zip>04530</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44260</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Israel</country>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2021</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>Thromboembolism</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apixaban</mesh_term>
  </intervention_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/NCT01707394
org study id: CV185-118
secondary id: 2012-001581-15
nct id: NCT01707394
lead sponsor: 
collaborator: 
has dmc: Yes
CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of
      this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for
      thrombosis
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban
time frame: Up to 26 hours, post dose (from Day 1 to Day 2)
measure: Maximum estimated plasma concentration (Cmax) of Apixaban
time frame: Up to 26 hours, post dose (from Day 1 to Day 2)
measure: Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban
time frame: Up to 26 hours, post dose (from Day 1 to Day 2)
measure: Number of participants with Adverse Events (AEs)
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Number of participants with Serious Adverse Events (SAEs)
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Change from baseline in Vital Signs of body temperature
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Change from baseline in Vital Signs of respiratory rate
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Change from baseline in Vital Signs of blood pressure
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Change from baseline in Vital Signs of heart rate
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Number of participants with abnormalities in Physical Examinations
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Change from baseline in Clinical Laboratory Tests of blood
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Change from baseline in Clinical Laboratory Tests of blood serum
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Change from baseline in International Normalized Ratio (INR) clotting activity during treatment
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Change from baseline in Prothrombin Time (PT) clotting activity during treatment
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Change from baseline in Clinical Laboratory Tests of urine
time frame: Up to 30 Days after last dosing
description: Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
measure: Pharmacodynamics will be analyzed using anti-Factor Xa activity
time frame: Up to 26 hours, post dose (from Day 1 to Day 2)
arm group label: Group 1: Apixaban (low dose)
arm group type: Experimental
arm group label: Group 2A: Apixaban (low dose)
arm group type: Experimental
arm group label: Group 2B: Apixaban (low dose)
arm group type: Experimental
arm group label: Group 3: Apixaban (low dose)
arm group type: Experimental
arm group label: Group 4: Apixaban (low dose)
arm group type: Experimental
arm group label: Group 5: Apixaban (low dose)
arm group type: Experimental
arm group label: Group 2A (higher dose): Apixaban (low dose)
arm group type: Experimental
intervention type: Drug
intervention name: Apixaban
description: Specified dose on specified days
arm group label: Group 1: Apixaban (low dose)
arm group label: Group 2A (higher dose): Apixaban (low dose)
arm group label: Group 2A: Apixaban (low dose)
arm group label: Group 2B: Apixaban (low dose)
arm group label: Group 3: Apixaban (low dose)
arm group label: Group 4: Apixaban (low dose)
arm group label: Group 5: Apixaban (low dose)
other name: BMS-562247
criteria: 
gender: All
minimum age: 1 Day
maximum age: 18 Years
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Australia
country: Canada
country: Israel
country: Mexico
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Thromboembolism
mesh term: Thrombosis
mesh term: Apixaban