Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338897
Status:
COMPLETED
Last Update Posted:
2008-12-10
First Post:
2006-06-19
Brief Title:
Dose Ranging Study in Elective Total Hip Replacement Surgery
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Double Dummy Parallel Group Dose Ranging Study of Subcutaneous SR123781A With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
Status:
COMPLETED
Status Verified Date:
2008-12
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:
DRIVE
Brief Summary:
The primary objective is to
demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism VTE by the demonstration of a dose-response in patients undergoing total hip replacement surgery
The secondary objectives are to
evaluate the safety of SR123781A in the prevention of VTE after elective total hip replacement surgery and
to assess the SR123781A pharmacokinetic profile in patients undergoing elective total hip replacement surgery
demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism VTE by the demonstration of a dose-response in patients undergoing total hip replacement surgery
The secondary objectives are to
evaluate the safety of SR123781A in the prevention of VTE after elective total hip replacement surgery and
to assess the SR123781A pharmacokinetic profile in patients undergoing elective total hip replacement surgery
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2006-000152-41 | None | None | None |