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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00077805 |
Purpose
Primary objective:
Secondary objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Ischemic Stroke |
Drug: Enoxaparin sodium |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | An Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in the Prevention of Venous Thromboembolism in Patients Following Acute Ischemic Stroke |
| Study Start Date: | August 2003 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| United States, New Jersey | |
| Sanofi-Aventis | |
| Bridgewater, New Jersey, United States | |
| Australia | |
| Sanofi-Aventis | |
| North Ryde, Australia | |
| Austria | |
| Sanofi-Aventis | |
| Vienna, Austria | |
| Brazil | |
| Sanofi-Aventis | |
| Sao Paulo, Brazil | |
| Canada | |
| Sanofi-Aventis | |
| Laval, Canada | |
| Colombia | |
| Sanofi-Aventis | |
| Bogota, Colombia | |
| Czech Republic | |
| Sanofi-Aventis | |
| Prague, Czech Republic | |
| India | |
| Sanofi-Aventis | |
| Mumbai, India | |
| Israel | |
| Sanofi-Aventis | |
| Natanya, Israel | |
| Italy | |
| Sanofi-Aventis | |
| Milan, Italy | |
| Korea, Republic of | |
| Sanofi-Aventis | |
| Seoul, Korea, Republic of | |
| Mexico | |
| Sanofi-Aventis | |
| Mexico, Mexico | |
| Poland | |
| Sanofi-Aventis | |
| Warsaw, Poland | |
| South Africa | |
| Sanofi-Aventis | |
| Johannesburg, South Africa | |
| Turkey | |
| Sanofi-Aventis | |
| Istanbul, Turkey | |
| Study Director: | Luc Sagnard | Sanofi-Aventis |
More Information
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00077805 History of Changes |
| Other Study ID Numbers: | XRP4563H_4001 |
| Study First Received: | February 12, 2004 |
| Last Updated: | January 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Ischemia Stroke Cerebral Infarction Thromboembolism Venous Thromboembolism Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
Embolism and Thrombosis Thrombosis Heparin Heparin, Low-Molecular-Weight Dalteparin Enoxaparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |