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

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01195727
First received: September 3, 2010
Last updated: December 27, 2012
Last verified: December 2012

September 3, 2010
December 27, 2012
July 2011
July 2012   (Final data collection date for primary outcome measure)
Pharmacokinetic (PK): Model-derived population & individual PK parameters (e.g., CL/F, Vc/F, KA) used to estimate steady state Cmax & AUC(TAU), Cmin & Tmax in each subject. Population PK model will be developed using plasma concentration vs time data [ Time Frame: Days 1, 2, Day 5, 6 or 7 and Day 11 ]
Same as current
Complete list of historical versions of study NCT01195727 on ClinicalTrials.gov Archive Site
Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis [ Time Frame: Days 1, 2, Day 5, 6 or 7 ]
Same as current
Not Provided
Not Provided
 
Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Venous Thromboembolism
Drug: Apixaban
Other Name: BMS-562247
  • Experimental: Group 5A - Apixaban (Low Dose)

    Group 5: 12 years to <18 years;

    0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days

    Intervention: Drug: Apixaban
  • Experimental: Group 5B - Apixaban (High Dose)

    Group 5: 12 years to <18 years;

    1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days

    Intervention: Drug: Apixaban
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
July 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Mexico,   Netherlands
 
 
NCT01195727
CV185-079
Yes
Not Provided
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Pfizer
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP