Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder
NCT01707394
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- 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
- 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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Descriptive Information | ||||
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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 |
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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 | 49 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |