Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
Stopped early · Phase 1
Conditions studied: Venous Thromboembolism
In brief
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.
Key facts
- Study ID
- NCT01195727
- Run by
- Bristol-Myers Squibb
- People needed
- 13
- Starts
- 2011-07-26
- Expected to finish
- 2012-07-16
- Last updated by the study team
- 2017-04-07
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children'S Hospital Of Orange County — Orange, California, United States
- Saint Peter'S University Hospital — New Brunswick, New Jersey, United States
- The Toledo Children'S Hospital — Toledo, Ohio, United States
- Penn State Hershey Children'S Hospital — Hershey, Pennsylvania, United States
- Local Institution — Brussels, Belgium
- Local Institution — Leuven, Belgium
- Local Institution — Edmonton, Alberta, Canada
- Local Institution — Ottawa, Ontario, Canada
- Local Institution — Guadalajara, Jalisco, Mexico
- Local Institution — Mexico City, Mexico City, Mexico
- Local Institution — Mexico City, Mexico City, Mexico
- Local Institution — Mexico, D. F., Mexico City, Mexico
- Local Institution — Puebla City, Puebla, Mexico
- Local Institution — Amsterdam, Netherlands
Full record on ClinicalTrials.gov
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