Apixaban for the Acute Treatment of Venous Thromboembolism in Children



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 17
Updated:4/6/2019
Start Date:November 22, 2015
End Date:April 29, 2021
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

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


Inclusion Criteria:

1. 3 months to <18 years of age with a minimum weight of 6 kg at the time of
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:

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 <50×109 per L at randomization.

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.
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700 Childrens Drive
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282 Washington St
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425 University Blvd.
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2500 N State St
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740 South Limestone Street
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