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.
We found this trial at
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
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740 South Limestone Street
Lexington, Kentucky 40536
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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747 52nd St
Oakland, California 94609
(510) 428-3000
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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Philadelphia, Pennsylvania 19134
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
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Tampa, Florida 33607
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Gainesville, Florida 32610
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Hollywood, Florida 33021
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Indianapolis, Indiana 46202
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Indianapolis, Indiana 46202
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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Loma Linda, California 92354
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Loma Linda, California 92354
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
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Los Angeles, California 90027
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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New Brunswick, New Jersey 08903
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630 W 168th St
New York, New York
212-305-2862
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Oakland, California 94612
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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Oklahoma City, Oklahoma 73104
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2501 North Orange Avenue
Orlando, Florida 32804
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
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Palo Alto, California 94304
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Palo Alto, California 94304
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3401 Civic Center Boulevard
Philadelphia, Pennsylvania 19104
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
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1600 Eureka Road
Roseville, California 95661
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San Antonio, Texas 78207
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7703 Floyd Curl Drive
San Antonio, Texas 78229
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250 East Caroline Street
San Bernardino, California 92408
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San Francisco, California 94158
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San Francisco, California 94143
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
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Sydney, New South Wales 2031
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750 East Adams Street
Syracuse, New York 13210
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West Palm Beach, Florida 33407
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5325 Greenwood Avenue
West Palm Beach, Florida 33407
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