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 |
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.
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
80
sites
747 52nd St
Oakland, California 94609
Oakland, California 94609
(510) 428-3000

Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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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
Cincinnati, Ohio 45229
1-513-636-4200

Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000

Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Atlanta, Georgia 30329
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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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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
Charleston, South Carolina 29425
843-792-1414

Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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6431 Fannin Street
Houston, Texas 77030
Houston, Texas 77030
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
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 08901
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458

University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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2501 North Orange Avenue
Orlando, Florida 32804
Orlando, Florida 32804
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Florida Hospital Florida Hospital is one of the country
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3401 Civic Center Boulevard
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
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Philadelphia, Pennsylvania 19134
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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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5325 Greenwood Avenue
West Palm Beach, Florida 33407
West Palm Beach, Florida 33407
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