Study to Evaluate a Single Dose of Apixaban in Pediatric Subjects at Risk for a Thrombotic Disorder



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 18
Updated:11/14/2018
Start Date:January 10, 2013
End Date:December 31, 2019
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:Clinical.Trials@bms.com

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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

CV185118 is a single dose Apixaban PK/PD study in pediatric subjects. The objective of this
study is primarily to study the PK/PD of Apixaban in pediatric subjects at risk for
thrombosis


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Subjects with any stable disease that are at risk for a venous or arterial thrombotic
disorder

- Neonates up to 28 days of age (>= 34 weeks gestational age or >= 37 weeks post
conceptual age) to <18 years of age

- Subjects with any functional CVAD (Central Venous Access Device) in the upper or lower
venous system

Exclusion Criteria:

- Current or recent (within 3 months of study drug administration) gastrointestinal
disease or gastrointestinal surgery that, in the opinion of the investigator and the
BMS Medical Monitor, could impact the absorption of the study drug

- Active bleeding or high risk of bleeding

- Inability to tolerate oral medication or administration of oral medication via an
enteral tube (nasogastric tube [NG tube] or gastronomy tube [G-tube])
We found this trial at
18
sites
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-756-7899
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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Des Moines, IA
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Phone: 860-545-9630
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Hartford, CT
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Phone: 714-532-8744
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Phone: 404-694-1317
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, GA
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Boston, Massachusetts 02111
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Boston, MA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Hershey, Pennsylvania 17033
Phone: 717-531-5656
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Hershey, PA
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Kansas City, Missouri 64108
Phone: 816-234-1119
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Kansas City, MO
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Phone: 501-364-1418
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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Louisville, Kentucky 40202
Phone: 502-629-5820
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Louisville, KY
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Phone: 414-266-3360
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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mi
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Milwaukee, WI
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254 Easton Ave
New Brunswick, New Jersey 08901
(732) 745-8600
Phone: 732-745-8600
Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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New Brunswick, NJ
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Parkville, Victoria
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Parkville,
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Pittsburgh, Pennsylvania 15224
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Pittsburgh, PA
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Toledo, Ohio 43606
Phone: 419-291-2743
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Toledo, OH
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Washington, District of Columbia 20007
Phone: 202-444-2224
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Washington,
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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