Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375609
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2006-09-11
Brief Title:
Factor Xa Inhibitor PRT054021 Against Enoxaparin for the Prevention of Venous Thromboembolic Events EXPERT
Sponsor:
Portola Pharmaceuticals
Organization:
Alexion Pharmaceuticals Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None