NCT00622648

Study to Evaluate the Mortality Reduction of Enoxaparin in Hospitalized Acutely Ill Medical Receiving Enoxaparin

International, Multi-center, Randomized, Double Blind Study to Compare the Overall Mortality in Acutely Ill Medical Patients Treated With Enoxaparin Versus Placebo in Addition to Graduated Elastic Stockings

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8,329 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The primary objective: * To demonstrate in patients hospitalized for an acute medical illness that enoxaparin with Graduated Elastic Stockings is superior to enoxaparin-placebo with Graduated Elastic Stockings on overall mortality at day 30 after randomization. The secondary objective: * To compare, in patients hospitalized for an acute medical illness, enoxaparin with Graduated Elastic Stockings versus enoxaparin placebo with Graduated Elastic Stockings on overall mortality at day 90 after randomization. * To evaluate the safety of enoxaparin VTE prophylaxis in patients hospitalized for acute medical illness with respect to major hemorrhage, total bleedings, heparin induced thrombocytopenia, adverse events and serious adverse events .

Conditions

• Acute Illness

Interventions

Type	Name	Description
DRUG	Enoxaparin	40 mg once daily for 6 to 14 days (10 ± 4 days)
DRUG	Placebo	Enoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days)

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-02-25
• Last updated: 2010-12-28

Locations

9 sites across 9 countries: Brazil, China, Hong Kong, India, Malaysia, Mexico, Philippines, South Korea, Tunisia