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

NCT01707394

Last updated date
Study Location
Local Institution
Iowa City, Iowa, 52242, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Thromboembolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-18
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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])

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Pfizer Clinical Trials Contact Center

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Advanced Information
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 up 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
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2020

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