SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
NCT ID: NCT00071279
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
1215 participants
INTERVENTIONAL
2003-11-30
2005-12-31
Brief Summary
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In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.
Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
DOUBLE
Interventions
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SR34006 (idraparinux sodium) Injection
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Indication for anticoagulation other than PE or DVT
* Creatinine clearance (CLcr) \<10 mL/min, severe hepatic disease, or bacterial endocarditis
* Participation in a pharmacotherapeutic study other than the Van Gogh-PE or DVT study within the prior 30 days
* Life expectancy \<3 months
* Patients in whom anticoagulation treatment for their index PE or DVT should be continued beyond 6 months
* Active bleeding or high risk for bleeding
* Uncontrolled hypertension: systolic blood pressure \>180 mm Hg or diastolic blood pressure \> 110 mm Hg
* Pregnancy, or childbearing potential without proper contraceptive measures, women who are breastfeeding.
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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Bay Pines VA Medical Center
Bay Pines, Florida, United States
Pulmonary Associates of Brandon
Brandon, Florida, United States
Jacksonville Cardiovascular Clinic
Jacksonville, Florida, United States
Melbourne Internal Medicine Associates (MIMA)
Melbourne, Florida, United States
Melbourne Internal Medical Associates (MIMA)
Palm Bay, Florida, United States
Clinical Pharmacology Services
Tampa, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
Cardinal Bernardin Cancer Center
Maywood, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office
Bloomfield Hills, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Joseph Mercy - Oakland Clinical Research Office
Pontiac, Michigan, United States
St. Joseph Mercy - Oakland
Pontiac, Michigan, United States
William Beaumont Hospital / Clinical Research Center
Royal Oak, Michigan, United States
William Beaumont Hospital Troy
Troy, Michigan, United States
Lovelace Sandia Health Systems, Clinical Thrombosis Center
Albuquerque, New Mexico, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Crozer-Chester Medical Center
Upland, Pennsylvania, United States
Lung & Chest Medical Associates
Spartanburg, South Carolina, United States
Spartanburg Pharmaceutical Research
Spartanburg, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
The Methodist Hospital
Houston, Texas, United States
Scott and White Memorial Hospital and Clinic
Temple, Texas, United States
The University of Texas Health Center at Tyler
Tyler, Texas, United States
Inova Alexandria Hospital
Alexandria, Virginia, United States
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Pulmonary Specialists/Spokane Respiratory Consultants
Spokane, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
Box Hill, Clayton, Coffs Harbour, Garran, Kogarah, , Australia
Premantle, Redcliffe, Saint Leonards, South Australia, , Australia
Ringwood East, Woolloongabba, , Australia
Graz, Wien, , Austria
Bruxelles, Duffel, Leuven, Lier, Zottegem, , Belgium
Porto Alegre, Salvador, Sao Paulo, , Brazil
University of Alberta
Edmonton, Alberta, Canada
Kelowna General Hospital
Kelowna, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec
Sainte-Foy, Quebec, Canada
Brno, Hradec Karlove, Jihlava, Karlovy Vary, Kladno, , Czechia
Ostrava-Poruba, Plzen, Prague, Usti Nad Labem, , Czechia
Arhus, Braedstrup, Frederiksberg, Glostrup, Hillerod, , Denmark
Kobenhavn, Odense, , Denmark
Seinäjoki, , Finland
Besancon, Brest, Chambray Les Tours, Clamart, Grenoble, , France
Montpellier, Paris, Rouen, Saint Brieuc, Saint Etienne, , France
Toulouse, Valenciennes, , France
Berlin, Bochum, Dresden, Heidelberg, Ibbenburen, Mannheim, , Germany
Genova, Milano, Padova, Parma, Pavia, Piacenza, Reggio Emilia, , Italy
Treviso, Venezia, , Italy
Alkmaar, Almere, Amersfoort, Amsterdam, Arnhem, Haarlem, , Netherlands
Maastricht, Nieuwegein, Sittard, Zwolle, , Netherlands
Auckland, , New Zealand
Oslo, Rud, , Norway
Bialystok, Szczecin, Warszawa, Wroclaw, , Poland
Bloemfontein, Bryanston, Durban, , South Africa
Barcelona, Madrid, Torrelavega, Xativa, , Spain
Goteborg, Jonkoping, Stockholm, Varnamo, Vastervik, , Sweden
London, , United Kingdom
Countries
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References
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van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Extended prophylaxis of venous thromboembolism with idraparinux. N Engl J Med. 2007 Sep 13;357(11):1105-12. doi: 10.1056/NEJMoa067703.
Related Links
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Related Info
Other Identifiers
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SR34006
Identifier Type: -
Identifier Source: secondary_id
EFC5135
Identifier Type: -
Identifier Source: org_study_id
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