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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Abd

Brief 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.

Detailed Summary:
Sponsor: Sanofi

Current Primary Outcome: Venous thromboembolism incidence [ Time Frame: 28 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism incidence except patients with thrombus only in muscle veins, and incidence of proximal vein thrombosis [ Time Frame: 28 days ]

Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: July 24, 2008
Date Started: March 2007
Date Completion:
Last Updated: April 2, 2010
Last Verified: April 2010