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Apixaban for the Acute Treatment of Venous Thromboembolism in Children

NCT02464969 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2024-10-29

Study results available
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Summary

To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Apixaban

Tablet or Solution

DRUG

Standard of Care

Unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For subjects under 2 years of age, standard of care will be limited to unfractionated heparin or low molecular weight heparin.

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-22
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Israel
  • Mexico
  • Russia
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02464969 on ClinicalTrials.gov