Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206089
Status:
TERMINATED
Last Update Posted:
2010-11-15
First Post:
2005-09-13
Brief Title:
MelagatranXimelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
The EXTEND Study A Randomized Double-blind Parallel-group Phase III b Multi-centre Study Evaluating Extended Prophylactic Treatment With MelagatranXimelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events in Patients Undergoing Elective Hip Replacement or Hip Fracture Surgery
Status:
TERMINATED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Melagatranximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXTEND
Brief Summary:
This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots compared with enoxaparin for a period of 5-6 weeks A separate visit independent from the study will be done approximately 6 months after the 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