Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331838
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2006-05-18
Brief Title:
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Double-Dummy Parallel Group Dose Response Study of Subcutaneous AVE5026 With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
Status:
COMPLETED
Status Verified Date:
2013-01
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:
TREK
Brief Summary:
The primary objective was to demonstrate the dose-response of Semuloparin sodium AVE5026 for the prevention of Venous Thromboembolism VTE in patients undergoing total knee replacement TKR surgery
Secondary objectives were to evaluate the safety incidence of major bleeding of AVE5026 to document the efficacy and safety of AVE5026 post-operative regimens and to assess the pharmacokinetic parameters of AVE5026
Secondary objectives were to evaluate the safety incidence of major bleeding of AVE5026 to document the efficacy and safety of AVE5026 post-operative regimens and to assess the pharmacokinetic parameters of AVE5026
Detailed Description:
The randomization had to take place before the first study drug injection
The total duration of observation per participant was 27-33 days from surgery broken down as follows
4 to 10-day double-blind treatment period
Follow-up period up to Day 30 3 after surgery
Mandatory bilateral venography of the lower limbs had to be performed between 5 to 11 days after surgery
The total duration of observation per participant was 27-33 days from surgery broken down as follows
4 to 10-day double-blind treatment period
Follow-up period up to Day 30 3 after surgery
Mandatory bilateral venography of the lower limbs had to be performed between 5 to 11 days after surgery
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 |
|---|---|---|---|
| 2005-006202-26 | EUDRACT_NUMBER | None | None |