Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00679588

Purpose

The primary objective of the study is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of AVE5026 with q.d. s.c. injections of enoxaparin after surgery for the prevention of venous thromboembolic events in patients undergoing major abdominal surgery.

The secondary objectives of this study are to evaluate the safety of AVE5026 and to document AVE5026 exposures in this population.

Condition	Intervention	Phase
Venous Thromboembolism	Drug: AVE5026 Drug: Enoxaparin	Phase III

Drug Information available for: Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multinational, Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Composite of any VTE and death from any cause [ Time Frame: From randomization up to the day of the event or the day of the mandatory venography; whichever comes first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy: Individual Components of the primary outcome measure [ Time Frame: From randomization up to the day of the event or the day of the mandatory venography; whichever comes first ] [ Designated as safety issue: No ]
Safety: Transfusions, bleeding events, laboratory data, adverse events [ Time Frame: Study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	4400
Study Start Date:	May 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AVE5026 once daily subcutaneous injection for 7 to 10 days after surgery
2: Active Comparator	Drug: Enoxaparin once daily subcutaneous injection for 7 to 10 days after surgery

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients undergoing major surgery of the abdomen and/or the pelvis
Patients <60 years must have one of the following additional risk factors:
- History of venous thrombo embolism
- Obesity
- Chronic Heart failure
- Chronic Respiratory Failure
- Inflammatory Bowel Disease
- Cancer Surgery

Exclusion Criteria:

Any major orthopedic or general surgery in the 3 months prior to study start
Clinical signs or symptoms of deep vein thrombosis or pulmonary embolism within the last 12 months or known post phlebitic syndrome
Any contra-indications to the performance of venography
Patients at high risk of bleeding
Known hypersensitivity to heparin or enoxaparin sodium

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679588

Contacts

Contact: Public Registry ICD

GV-Contact-us@sanofi-aventis.com

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office	Recruiting
Bridgewater, New Jersey, United States, 08807
Contact GV-Contact-us@sanofi-aventis.com
Belgium
Sanofi-Aventis Administrative Office	Not yet recruiting
Diegem, Belgium
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Canada
Sanofi-Aventis Administrative Office	Recruiting
Laval, Canada
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Czech Republic
Sanofi-Aventis Administrative Office	Recruiting
Praha, Czech Republic
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Denmark
Sanofi-Aventis Administrative Office	Recruiting
Horsholm, Denmark
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Estonia
Sanofi-Aventis Administrative Office	Recruiting
Tallinn, Estonia
Contact GV-Contact-us@sanofi-aventis.com
Hungary
Sanofi-Aventis Administrative Office	Not yet recruiting
Budapest, Hungary
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India
Sanofi-Aventis Administrative Office	Recruiting
Mumbai, India
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Latvia
Sanofi-Aventis Administrative Office	Recruiting
Riga, Latvia
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Lithuania
Sanofi-Aventis Administrative Office	Not yet recruiting
Vilnius, Lithuania
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New Zealand, New South Wales
sanofi-aventis Australia & New Zealand administrative office	Recruiting
Macquarie Park, New South Wales, New Zealand
Contact GV-Contact-us@sanofi-aventis.com
Norway
Sanofi-Aventis Administrative Office	Recruiting
Lysaker, Norway
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Ukraine
Sanofi-Aventis Administrative Office	Recruiting
Kiev, Ukraine
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Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:	Ajay Kakkar, Prof., MD, PhD	Queen Mary's School of Medicine & Dentistry, London (UK)
Study Chair:	Alexander Turpie, MD	HHS-General Hospital, Hamilton, Canada

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC6520, EudraCT 2007-007942-36
Study First Received:	May 7, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00679588
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Digestive System Surgical Procedure
Urologic Surgical Procedure
Prevention of venous thromboembolism
Abdominal surgery

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases
Venous Thromboembolism

Thrombosis
Thromboembolism
Enoxaparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009