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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Thromboembolism Drug: Apixaban Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : January 10, 2013
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
Drug Information available for: Apixaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: Apixaban (low dose) Drug: Apixaban
Specified dose on specified days
Other Name: BMS-562247
Experimental: Group 2A: Apixaban (low dose) Drug: Apixaban
Specified dose on specified days
Other Name: BMS-562247
Experimental: Group 2B: Apixaban (low dose) Drug: Apixaban
Specified dose on specified days
Other Name: BMS-562247
Experimental: Group 3: Apixaban (low dose) Drug: Apixaban
Specified dose on specified days
Other Name: BMS-562247
Experimental: Group 4: Apixaban (low dose) Drug: Apixaban
Specified dose on specified days
Other Name: BMS-562247
Experimental: Group 5: Apixaban (low dose) Drug: Apixaban
Specified dose on specified days
Other Name: BMS-562247
Experimental: Group 2A (higher dose): Apixaban (low dose) Drug: Apixaban
Specified dose on specified days
Other Name: BMS-562247


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. Maximum estimated plasma concentration (Cmax) of Apixaban [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ]
  3. 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) ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Pharmacodynamics will be analyzed using anti-Factor Xa activity [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ]

Eligibility Criteria
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Ages Eligible for Study:   1 Day to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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])
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707394


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01707394    
Other Study ID Numbers: CV185-118
2012-001581-15 ( EudraCT Number )
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Thromboembolism
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Apixaban
Factor Xa Inhibitors
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants