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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00338897 |
The primary objective is to:
The secondary objectives are to:
Condition | Intervention | Phase |
---|---|---|
Venous Thromboembolism |
Drug: SR123781A |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Double Dummy, Parallel Group, Dose Ranging Study of Subcutaneous SR123781A With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery |
Enrollment: | 1090 |
Study Start Date: | May 2006 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (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:
Argentina, Buenos Aires | |
Sanofi-Aventis | |
San Isidro, Buenos Aires, Argentina, 1642 | |
Bulgaria | |
Sanofi-Aventis | |
Sofia, Bulgaria, 1715 | |
Chile, Santiago | |
Sanofi-Aventis | |
Providencia, Santiago, Chile | |
Colombia | |
Sanofi-Aventis | |
Santafe de Bogota, Colombia | |
Czech Republic | |
Sanofi-Aventis | |
Praha, Czech Republic, 160 00 | |
Denmark | |
Sanofi-Aventis | |
Denmark, Denmark | |
Finland | |
Sanofi-Aventis | |
Helsinki, Finland | |
Mexico | |
Sanofi-Aventis | |
Mexico, Mexico, 04000 | |
Norway | |
Sanofi-Aventis | |
Oslo, Norway | |
Poland | |
Sanofi-Aventis | |
Warszawa, Poland | |
Romania | |
Sanofi-Aventis | |
Bucuresti, Romania, 70334 | |
Russian Federation | |
Sanofi-Aventis | |
Moscow, Russian Federation, 101000 | |
Sweden | |
Sanofi-Aventis | |
Bromma, Sweden | |
Turkey | |
Sanofi-Aventis | |
Istanbul, Turkey, 34394 |
Study Chair: | Michael Rud Lassen, MD | Hoersholm Hospital, Spine Clinic, Usserod Kongevej 102, DK-2970 Hoerholm, Denmark |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | DRI5664, EudraCT : 2006-000152-41 |
Study First Received: | June 19, 2006 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00338897 |
Health Authority: | Russia: Pharmacological Committee, Ministry of Health; Romania: National Medicines Agency; Turkey: Ethics Committee |
Venous Thromboembolism Prevention Arthroplasty |
Replacement Hip orthopedic surgery |
Embolism and Thrombosis Embolism Vascular Diseases Venous Thromboembolism |
Thrombosis Thromboembolism Enoxaparin |
Cardiovascular Diseases |