Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)
NCT ID: NCT00067093
Last Updated: 2011-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1452 participants
INTERVENTIONAL
2003-05-31
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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SanOrg34006
LMW heparin
Unfractionated heparin
Vitamin K antagonist (VKA)
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Patients with symptomatic pulmonary embolism
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
* Other indication for VKA than DVT
* More than 36 hours before the treatment with therapeutic dosages of low molecular weight heparin or initiation of VKA treatment prior to randomization
* Participation in another pharmacotherapeutic study within the prior 30 days
* Creatinine clearance \<10mL/min, severe hepatic disease or bacterial endocarditis
* Life expectancy \<3 Months
* Active bleeding or high risk for bleeding
* Uncontrolled hypertension: systolic blood pressure \>180 mm Hg and diastolic blood pressure \>110 mm Hg.
* Pregnancy or childbearing potential without proper contraceptive measures
* Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin (UFH), enoxaparin, or tinzaparin
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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University of Colorado Health Sciences Center
Denver, Colorado, United States
Jackson Cardio-Vascular Clinic
Jacksonville, Florida, United States
MIMA Century Research Associates
Melbourne, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
DeKalb Medical Center
Decatur, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Evanston Northwestern Healthcare
Evanston, Illinois, United States
Loyola University of Chicago
Maywood, Illinois, United States
Consultants in Pulmonary Medicine
Olathe, Kansas, United States
Boston Medical Center
Boston, Massachusetts, United States
St. Joseph Mercy - Oakland Research Center
Pontiac, Michigan, United States
Lovelace Health Systems
Albuquerque, New Mexico, United States
North Shore University Hospital
Manhasset, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Health System Research Center
Grand Forks, North Dakota, United States
University of Oklahoma HSC
Oklahoma City, Oklahoma, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
James Muntz
Houston, Texas, United States
Scott and White Memorial Hospital & Clinic
Temple, Texas, United States
Inova Alexandria Hospital
Alexandria, Virginia, United States
Pulmonary Associates
Fredericksburg, Virginia, United States
McGuire VAMC
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
William Dittman
Spokane, Washington, United States
Countries
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References
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Prins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.
van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med. 2007 Sep 13;357(11):1094-104. doi: 10.1056/NEJMoa064247.
Related Links
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Related Info
Other Identifiers
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SR34006
Identifier Type: -
Identifier Source: secondary_id
EFC3491
Identifier Type: -
Identifier Source: org_study_id
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