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. |
| NCT00077844 ↗ | Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI) Patients, an International Randomized Evaluation (STEEPLE) | Completed | Sanofi | Phase 2/Phase 3 | 2004-01-01 | The purpose of this study is to evaluate the efficacy and safety of intravenous enoxaparin versus intravenous unfractionated heparin (UFH) in patients undergoing non-emergent PCI, as assessed by measuring the incidence of non-coronary artery bypass graft (CABG) major and minor bleeding. |
| NCT00191724 ↗ | Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study | Completed | Eli Lilly and Company | Phase 2 | 2004-09-01 | An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium. |
| NCT00232271 ↗ | The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation. | Terminated | National Heart Foundation, Australia | Phase 4 | 2005-08-01 | The purpose of this study is to assess the effect of the anticoagulant(blood thinner) Clexane on the development of leg clots following electrophysiology studies (EPS) and or radiofrequency ablation (RFA). People who suffer heart palpitations will sometimes need hospital admission to undergo an electrophysiology study ( and or a Radiofrequency Ablation)in order to diagnose and or treat their condition. Radiofrequency ablation is a procedure to stop abnormal heart rhythms. EPS/RFA studies require the puncture of the leg veins . Previous experience has shown that following the puncture of leg veins there is a small risk of developing a blood clot in the leg. It is not known whether giving blood thinners (anticoagulants) after the procedure will decrease this risk Enoxaparin Sodium (Clexane) is an anticoagulant used extensively and safely following bone (Orthopaedic) surgery to prevent blood clots from developing in the legs |
| NCT00232271 ↗ | The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation. | Terminated | Sanofi | Phase 4 | 2005-08-01 | The purpose of this study is to assess the effect of the anticoagulant(blood thinner) Clexane on the development of leg clots following electrophysiology studies (EPS) and or radiofrequency ablation (RFA). People who suffer heart palpitations will sometimes need hospital admission to undergo an electrophysiology study ( and or a Radiofrequency Ablation)in order to diagnose and or treat their condition. Radiofrequency ablation is a procedure to stop abnormal heart rhythms. EPS/RFA studies require the puncture of the leg veins . Previous experience has shown that following the puncture of leg veins there is a small risk of developing a blood clot in the leg. It is not known whether giving blood thinners (anticoagulants) after the procedure will decrease this risk Enoxaparin Sodium (Clexane) is an anticoagulant used extensively and safely following bone (Orthopaedic) surgery to prevent blood clots from developing in the legs |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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