CLINICAL TRIALS PROFILE FOR ENOXAPARIN SODIUM
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All Clinical Trials for ENOXAPARIN SODIUM
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00077753 ↗ | EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization | Completed | Sanofi | Phase 4 | 2002-02-01 | Primary objective: - To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd Secondary objectives: - To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis - To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study - To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes: - Major and minor hemorrhage - Heparin induced thrombocytopenia - Serious adverse events - To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo. |
| NCT00077805 ↗ | PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin) | Completed | Sanofi | Phase 4 | 2003-08-01 | Primary objective: - To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 ± 4 days following acute ischemic stroke. Secondary objectives: - To compare the incidence of VTE between the 2 treatment groups at 30, 60, and 90 days from the time of randomization - To compare neurologic outcomes between the 2 treatment groups, including incidence of stroke recurrence, rate of stroke progression, and patient functional status, during the 10 ± 4 days of treatment, and after 30, 60, and 90 days from the time of randomization - To evaluate the safety of using enoxaparin compared to UFH for VTE prevention in patients following acute ischemic stroke |
| NCT00077818 ↗ | Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome (RESCUE) | Completed | Sanofi | Phase 4 | 2002-06-01 | The purpose of this study is to determine the efficacy and safety of enoxaparin compared to unfractionated heparin (UFH) for patients diagnosed with Acute Coronary Syndrome (ACS) in the emergency department (ED). Efficacy is assessed by using a composite score consisting of 30-day all-cause mortality, non-fatal myocardial infarction (MI) and recurrent angina requiring revascularization. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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