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Study 5 of 3601 for search of: | United States, Virginia |
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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00062803 |
Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.
Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.
Condition | Intervention | Phase |
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Pulmonary Embolism |
Drug: SR34006 Drug: (LMW)heparin Drug: Warfarin VKA Drug: Acenocoumarol VKA |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Safety/Efficacy Study |
Official Title: | The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism |
Study Start Date: | June 2003 |
Study Completion Date: | October 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC3484/64714 |
Study First Received: | June 16, 2003 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00062803 |
Health Authority: | United States: Food and Drug Administration |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism Acenocoumarol Lung Diseases |
Vitamin K Vascular Diseases Warfarin Heparin Thrombosis Calcium heparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |