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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00077753 |
Primary objective:
Secondary objectives:
To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes:
Condition | Intervention | Phase |
---|---|---|
Venous Thromboembolism |
Drug: enoxaparin sodium |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization |
Estimated Enrollment: | 4726 |
Study Start Date: | February 2002 |
Study Completion Date: | February 2007 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Level 2 mobility patients who
Anticipated decreased level of mobility of 5 ± 2 days with a level of activity 1 and 2 at the time of study entry and likely to continue at a lower than pre-morbid activity level after the initial 5 ± 2 day period. PATIENTS DO NOT HAVE TO BE HOSPITALIZED IN ORDER TO BE INCLUDED IN THE STUDY.(Definition of decreased level of mobility: _Level 1:bed rest or sedentary patients _Level 2:level 1 with bathroom privileges)
Presence of at least one of the following medical conditions:
Heart Failure, NYHA class III and IV
Other acute medical conditions such as:
Exclusion criteria:
Study Director: | Luc Sagnard | Sanofi-Aventis |
Study ID Numbers: | XRP4563C/3501 |
Study First Received: | February 12, 2004 |
Last Updated: | January 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00077753 |
Health Authority: | United States: Food and Drug Administration |
Embolism and Thrombosis Embolism Vascular Diseases Venous Thromboembolism |
Thrombosis Thromboembolism Enoxaparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |