Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077753
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2004-02-12
Brief Title:
EXCLAIMExtended Prophylaxis for Venous ThromboEmbolism VTE in Acutely Ill Medical Patients With Prolonged Immobilization
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Parallel Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective
To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 4 days compared to placebo both following 10 4 days of initial treatment with enoxaparin 40mg sc qd
Secondary objectives
To assess the reduction in mortality rate at the end of the double-blind treatment period at 3 90 10 days and at 6 180 10 days months from the time of entry to the study in patients on extended prophylaxis
To assess the incidence of VTE at 3 months 90 10 days from the time of randomization to the study
To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization Safety evaluation includes
Major and minor hemorrhage
Heparin induced thrombocytopenia
Serious adverse events
To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo
To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 4 days compared to placebo both following 10 4 days of initial treatment with enoxaparin 40mg sc qd
Secondary objectives
To assess the reduction in mortality rate at the end of the double-blind treatment period at 3 90 10 days and at 6 180 10 days months from the time of entry to the study in patients on extended prophylaxis
To assess the incidence of VTE at 3 months 90 10 days from the time of randomization to the study
To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization Safety evaluation includes
Major and minor hemorrhage
Heparin induced thrombocytopenia
Serious adverse events
To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo
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