Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter



Status:Terminated
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:12 - 17
Updated:4/8/2017
Start Date:July 26, 2011
End Date:July 16, 2012

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Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter

CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in
pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban
in pediatric subjects with a central venous catheter.


Inclusion Criteria:

- Subjects with chronic stable disease with any type of functioning CVC in the upper or
lower venous system (e.g., jugular, subclavian; femoral vein) that is anticipated to
remain in the subject for the treatment portion of the study.

- > 12 to <18 years of age

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
We found this trial at
5
sites
99-101 Belliardstraat
Bruxelles, 1040
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
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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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Children's Hospital Penn State Milton S. Hershey Medical Center, Penn State College...
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Hershey, PA
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254 Easton Ave
New Brunswick, New Jersey 08901
(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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Toledo, Ohio 43606
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Toledo, OH
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