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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1 Perkins Square
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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9500 Euclid Avenue
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700 Childrens Drive
Columbus, Ohio 43205
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282 Washington St
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425 University Blvd.
Indianapolis, Indiana 46202
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2500 N State St
Jackson, Mississippi 39216
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740 South Limestone Street
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1211 Medical Center Dr
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747 52nd St
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South 34th Street
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601 Elmwood Avenue
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300 Longwood Ave
Boston, Massachusetts 02115
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171 Ashley Avenue
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3901 Beaubien St
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2301 Erwin Rd
Durham, North Carolina 27710
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Gainesville, Florida 32610
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30 Prospect Ave
Hackensack, New Jersey 07601
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200 Hawkins Dr,
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Los Angeles, California 90027
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
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2501 North Orange Avenue
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601 E Rollins St
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1919 E Thomas Rd
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1600 Eureka Road
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250 East Caroline Street
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San Francisco, California 94143
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4800 Sand Point Way NE
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Sydney, New South Wales 2031
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750 East Adams Street
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