Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Sanofi-Aventis Organon |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00038961 |
This study is a randomized, double-blind, deep vein thrombosis (DVT) prevention trial in patients undergoing major abdominal surgery in 80 U.S. centers.
All patients receive background treatment of intermittent pneumatic compression devices. All subjects are assessed for DVTs with bilateral venography at the end of the study drug treatment period (day 5-9).
Condition | Intervention | Phase |
---|---|---|
Venous Thrombosis |
Drug: Fondaparinux Sodium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression Versus Intermittent Pneumatic Compression Used Alone for the Prevention of Venous Thromboembolic Events in Patients at Increased Risk Undergoing Major Abdominal Surgery |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC3558, SR90107A, ARIXTRA, ORG31540 |
Study First Received: | June 5, 2002 |
Last Updated: | April 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00038961 History of Changes |
Health Authority: | United States: Food and Drug Administration |
DVT Prevention Major Abdominal Surgery Venous Thromboembolic |
Fibrin Modulating Agents Embolism and Thrombosis Anticoagulants Embolism Vascular Diseases Fibrinolytic Agents |
Fondaparinux Venous Thrombosis Cardiovascular Agents Org 31540 Thrombosis |
Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Agents Vascular Diseases Fondaparinux Fibrinolytic Agents Cardiovascular Agents Thrombosis |
Org 31540 Pharmacologic Actions Embolism and Thrombosis Fibrin Modulating Agents Therapeutic Uses Venous Thrombosis Cardiovascular Diseases |