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Apixaban for the Acute Treatment of Venous Thromboembolism in Children

Last updated on June 7, 2019

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Study Location
Children's of Alabama Research Pharmacy
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Venous Thromboembolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-17 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. 3 months to randomization.

2. Presence of an index VTE which is confirmed by imaging.

3. Intention to manage the index VTE with anticoagulation treatment for at least 12
weeks.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Anticoagulant treatment for the index VTE for greater than 7 days prior to
randomization.

2. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index
VTE.

3. A mechanical heart valve.

4. Active bleeding or high risk of bleeding at the time of randomization.

5. Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to
randomization.

6. Abnormal baseline liver function at randomization.

7. Inadequate renal function at the time of randomization.

8. Platelet count

9. Uncontrolled severe hypertension at the time of randomization.

10. Use of prohibited concomitant medication at the time of randomization.

11. Female subjects who are either pregnant or breastfeeding a child.

NCT02464969
Pfizer
Recruiting
Apixaban for the Acute Treatment of Venous Thromboembolism in Children

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Pfizer Clinical Trials Contact Center

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[email protected]

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Venous Thromboembolism
NCT02464969
All Genders
0+
Years
Multiple Sites

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]

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