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Sponsored by: |
Portola Pharmaceuticals |
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Information provided by: | Portola Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00375609 |
Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the prophylaxis of venous thromboembolic events after unilateral knee replacement surgery.
Condition | Intervention | Phase |
---|---|---|
Thromboembolism |
Drug: PRT054021 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Factor Xa Inhibitor, PRT054021, Against Enoxaparin in a Randomized Trial for the Prevention of Venous Thromboembolic Events After Unilateral Total Knee Replacement (EXPERT) |
Estimated Enrollment: | 200 |
Study Start Date: | May 2006 |
Study Completion Date: | January 2007 |
Approximately 200 patients undergoing unilateral knee replacement will be entered into the study and randomized to receive either enoxaparin 30 mg sq bid, PRT054021 15 mg po bid, or PRT054021 40 mg po bid for 10 to 14 days, at which time patients will undergo venography.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Demographic
Ethical
Exclusion Criteria:
Disease Related
Laboratory and Procedures
Evidence at Screening of:
Medications
Study ID Numbers: | PRT05-003 |
Study First Received: | September 11, 2006 |
Last Updated: | September 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00375609 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Prevention of Venous Thromboembolism |
Serine Proteinase Inhibitors Embolism and Thrombosis Anticoagulants Embolism Vascular Diseases Venous Thromboembolism |
Antithrombin III Thrombosis Thromboembolism Protease Inhibitors Enoxaparin |
Serine Proteinase Inhibitors Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Agents Vascular Diseases Enzyme Inhibitors Thromboembolism |
Thrombosis Pharmacologic Actions Protease Inhibitors Embolism and Thrombosis Therapeutic Uses Cardiovascular Diseases Antithrombin III |