Clinical Trials Directory

Trials / Completed

CompletedNCT00723216

Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery

Multicenter, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium (RP54563) 20mg Bid for 14 Days for Prevention of Venous Thromboembolism in Patients With Curative Abdominal Cancer Surgery. Physical Prophylaxis Only Arm [Intermittent Pneumatic Compression (IPC)] Will be Used as an Indicator of Event Rates.

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
151 (actual)
Sponsor
Sanofi · Industry
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

Summary

The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.

Conditions

Interventions

TypeNameDescription
DRUGenoxaparin20 mg twice a day
OTHERPhysical prophylaxis

Timeline

Start date
2007-03-01
Primary completion
2007-12-01
Completion
2007-12-01
First posted
2008-07-28
Last updated
2010-04-05

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT00723216. Inclusion in this directory is not an endorsement.