Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT00709904
Status:
COMPLETED
Last Update Posted:
2013-06-14
First Post:
2008-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Placebo for the Extended Prevention of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery
Status:
COMPLETED
Status Verified Date:
2013-06
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:
SAVE-HIP3
Brief Summary:
The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery.
The secondary objective is to evaluate the safety of extended AVE5026 administration.
The secondary objective is to evaluate the safety of extended AVE5026 administration.
Detailed Description:
The total duration of observation per participant is 56-63 days from surgery broken down as follows:
* 7 to 10-day initial treatment period with open-label Semuloparin sodium;
* Randomization;
* 19 to 23-day double-blind treatment period with Semuloparin sodium or placebo;
* 30-day follow-up period.
Mandatory bilateral venography of the lower limbs is to be performed between 19 and 24 days after randomization.
* 7 to 10-day initial treatment period with open-label Semuloparin sodium;
* Randomization;
* 19 to 23-day double-blind treatment period with Semuloparin sodium or placebo;
* 30-day follow-up period.
Mandatory bilateral venography of the lower limbs is to be performed between 19 and 24 days after randomization.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-007947-28 | EUDRACT_NUMBER | None | View |