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

Tracking Information
First Received Date ^ICMJE	June 5, 2002
Last Updated Date	April 25, 2008
Start Date ^ICMJE	October 2001
Primary Completion Date	July 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00038961 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety Study of Fondaparinux Sodium to Prevent Venous Thromboembolic Events (APOLLO)
Official Title ^ICMJE	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
Brief Summary	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).
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Venous Thrombosis
Intervention ^ICMJE	Drug: Fondaparinux Sodium
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1070
Completion Date	July 2004
Primary Completion Date	July 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00038961
Responsible Party	ICD Study Director, sanofi-aventis
Study ID Numbers ^ICMJE	EFC3558, SR90107A, ARIXTRA, ORG31540
Study Sponsor ^ICMJE	Sanofi-Aventis
Collaborators ^ICMJE	Organon
Investigators ^ICMJE
Information Provided By	Sanofi-Aventis
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP