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Sponsored by: |
The Medicines Company |
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Information provided by: | The Medicines Company |
ClinicalTrials.gov Identifier: | NCT00043277 |
The goals of this study are:
Condition | Intervention | Phase |
---|---|---|
Thrombosis |
Drug: Angiomax (bivalirudin) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Dose Finding And Efficacy Study Of Angiomax® (Bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis |
Estimated Enrollment: | 25 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | December 2004 |
The goals of this study are:
Ages Eligible for Study: | up to 6 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Children's Hospital of Orange County | |
Orange, California, United States, 92868 |
Principal Investigator: | Guy Young, MD | Children's Hospital Orange County |
Study ID Numbers: | TMC-BIV-02-04 |
Study First Received: | August 7, 2002 |
Last Updated: | January 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00043277 |
Health Authority: | United States: Food and Drug Administration |
neonates thrombosis bivalirudin direct thrombin inhibitor |
Thrombin Signs and Symptoms Embolism and Thrombosis Embolism |
Bivalirudin Vascular Diseases Thrombosis |
Anticoagulants Therapeutic Uses Hematologic Agents Cardiovascular Diseases Pharmacologic Actions |