We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01707394
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 12, 2012
First Posted Date  ICMJE October 16, 2012
Last Update Posted Date March 22, 2021
Actual Study Start Date  ICMJE January 10, 2013
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2012)
  • Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ]
  • Maximum estimated plasma concentration (Cmax) of Apixaban [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ]
  • Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2019)
  • Number of participants with Adverse Events (AEs) [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Change from baseline in Vital Signs of body temperature [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Change from baseline in Vital Signs of respiratory rate [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Change from baseline in Vital Signs of blood pressure [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Change from baseline in Vital Signs of heart rate [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Number of participants with abnormalities in Physical Examinations [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Change from baseline in Clinical Laboratory Tests of blood [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Change from baseline in Clinical Laboratory Tests of blood serum [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Change from baseline in International Normalized Ratio (INR) clotting activity during treatment [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Change from baseline in Prothrombin Time (PT) clotting activity during treatment [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Change from baseline in Clinical Laboratory Tests of urine [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Pharmacodynamics will be analyzed using anti-Factor Xa activity [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2012)
  • Safety is measured by adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
  • Pharmacodynamics will be measured by anti-Factor Xa confirmed by analysis of anti-Factor Xa [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder
Official Title  ICMJE 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
Brief Summary CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Thromboembolism
Intervention  ICMJE Drug: Apixaban
Specified dose on specified days
Other Name: BMS-562247
Study Arms  ICMJE
  • Experimental: Group 1: Apixaban (low dose)
    Intervention: Drug: Apixaban
  • Experimental: Group 2A: Apixaban (low dose)
    Intervention: Drug: Apixaban
  • Experimental: Group 2B: Apixaban (low dose)
    Intervention: Drug: Apixaban
  • Experimental: Group 3: Apixaban (low dose)
    Intervention: Drug: Apixaban
  • Experimental: Group 4: Apixaban (low dose)
    Intervention: Drug: Apixaban
  • Experimental: Group 5: Apixaban (low dose)
    Intervention: Drug: Apixaban
  • Experimental: Group 2A (higher dose): Apixaban (low dose)
    Intervention: Drug: Apixaban
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2020)		 49
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2012)		 40
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Inclusion Criteria:

  • Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder

  • Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to <18 years of age

    • Gestational and post-conceptual age will only be taken into consideration for eligibility up to 6 months of age
    • Neonates: defined as newly born (within 4 weeks)
  • Participants 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])
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Day to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Israel,   Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01707394
Other Study ID Numbers  ICMJE CV185-118
2012-001581-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date March 2021

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