Safety Study of Fondaparinux Sodium to Prevent Venous Thromboembolic Events (APOLLO)

This study has been completed.

First Received: June 5, 2002 Last Updated: April 25, 2008 History of Changes

Sponsor:	Sanofi-Aventis
Collaborator:	Organon
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00038961

Purpose

This study is a randomized, double-blind, deep vein thrombosis (DVT) prevention trial in patients undergoing major abdominal surgery in 80 U.S. centers. All patients receive background treatment of intermittent pneumatic compression devices. All subjects are assessed for DVTs with bilateral venography at the end of the study drug treatment period (day 5-9).

Condition	Intervention	Phase
Venous Thrombosis	Drug: Fondaparinux Sodium	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression Versus Intermittent Pneumatic Compression Used Alone for the Prevention of Venous Thromboembolic Events in Patients at Increased Risk Undergoing Major Abdominal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis Surgery

Drug Information available for: ORG 31540 Fondaparinux sodium

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Estimated Enrollment:	1070
Study Start Date:	October 2001
Estimated Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Undergoing abdominal surgery (any surgery between the diaphragm and pelvic floor) lasting longer than 45 minutes (duration from anesthesia induction to surgical closure)
Over 40 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038961

Show 31 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Organon

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC3558, SR90107A, ARIXTRA, ORG31540
Study First Received:	June 5, 2002
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00038961 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

DVT Prevention
Major Abdominal Surgery
Venous Thromboembolic

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fondaparinux
Fibrinolytic Agents
Cardiovascular Agents
Thrombosis

Org 31540
Pharmacologic Actions
Embolism and Thrombosis
Fibrin Modulating Agents
Therapeutic Uses
Venous Thrombosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 09, 2009