Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events (EXTEND)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||The "EXTEND" Study: A Randomized, Double-blind, Parallel-group, Phase III b, Multi-centre Study Evaluating Extended Prophylactic Treatment With Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events in Patients Undergoing Elective Hip Replacement or Hip Fracture Surgery.|
- Non-inferiority for the prevention of VTE or VTE related death
- Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion.
|Study Start Date:||September 2005|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
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|Study Director:||AstraZeneca Medical Science Director, MD||AstraZeneca|