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

NCT00622648 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8329

Last updated 2010-12-28

No results posted yet for this study

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

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)

Sponsors & Collaborators

Principal Investigators

  • Bruno DESLANDES · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Brazil
  • China
  • Hong Kong
  • India
  • Malaysia
  • Mexico
  • Philippines
  • South Korea
  • Tunisia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00622648 on ClinicalTrials.gov