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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
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
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Mexico,   Netherlands
 
NCT01195727
CV185-079
Yes
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