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Also known as Enoxaparin sodium, enoxaparin (XRP4563), Enoxaparin sodium (XRP4563), Lovenox®
Enoxaparin · 8 trials · 10 indications
VTE included any Deep Vein Thrombosis \[DVT\] (proximal or distal, symptomatic or not) and non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths included fatal PE and deaths for other reason than PE.
| Arm | Type | Description |
|---|---|---|
| Semuloparin | EXPERIMENTAL | Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment \[SRI\]) once daily for 7-10 days with an initial dose given 8 hours after surgery Placebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind |
| Enoxaparin | ACTIVE_COMPARATOR | Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment \[SRI\]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium Placebo for Semuloparin sodium 8 hours after surgery to maintain the blind |
| 1 | ACTIVE_COMPARATOR | Enoxaparin |
| 2 | OTHER | Intermittent Pneumatic Compression (IPC) |
| A | EXPERIMENTAL | 70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 4 hours following the last injection of enoxaparin |
| B | EXPERIMENTAL | 70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 6 hours following the last injection of enoxaparin |
| C | EXPERIMENTAL | 70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 10 hours following the last injection of enoxaparin |
| Name | Type | Description |
|---|---|---|
| Enoxaparin sodium | DRUG | 0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection |
| Semuloparin sodium | DRUG | 0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection |
| Placebo | DRUG | 0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component Subcutaneous injection |
| enoxaparin | DRUG | 20 mg twice a day |
| Physical prophylaxis | OTHER | - |
| enoxaparin (XRP4563) | DRUG | 14 days of treatment |
| Enoxaparin sodium (XRP4563) | DRUG | - |
Inclusion Criteria: * Standard surgery for fracture of the upper third of the femur including femoral head and neck. Exclusion Criteria: * Estimated time of injury/fracture \> 24 hours before admission to hospital; * Any major orthopedic surgery in the 3 months prior to study start; * Multiple tr...
Enoxaparin is a small molecule drug developed by Sanofi (ticker SNY). It has been studied in Phase 3 clinical development across several conditions, including abdominal neoplasms, hip fracture surgery, hip replacement arthroplasty, myocardial infarction, percutaneous coronary intervention, and thrombosis. It is also known as enoxaparin sodium and enoxaparin (XRP4563).
Enoxaparin has been studied for use in abdominal neoplasms, hip fractures, hip replacement arthroplasty, myocardial infarction, percutaneous coronary intervention, and thrombosis. Its clinical program includes a Phase 3 trial in patients with curative abdominal cancer surgery and Phase 3 trials in patients undergoing hip fracture surgery.
Enoxaparin is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor associated with the clinical development program for enoxaparin and its alternative names, enoxaparin sodium and enoxaparin (XRP4563).
Enoxaparin is in Phase 3 clinical development. Its trial record includes Phase 3 studies in abdominal neoplasms and hip fracture surgery, along with a completed Phase 1 study in thrombosis. The Phase 3 program includes a completed Japanese efficacy and safety study in patients with curative abdominal cancer surgery.
Enoxaparin has been evaluated in completed trials including NCT00723216, a Phase 3 Japanese efficacy and safety study in patients with curative abdominal cancer surgery, NCT00721760, a Phase 3 study of AVE5026 compared with enoxaparin for thromboembolism prevention in hip fracture surgery, NCT00685958, a Phase 3 Japanese hip fracture surgery study, and NCT00622115, a Phase 1 study in thrombosis.
Yes. Enoxaparin is also known as enoxaparin sodium and enoxaparin (XRP4563). These names refer to the same Sanofi-developed small molecule. Searches for enoxaparin sodium or XRP4563 refer to the same clinical development program covering abdominal neoplasms, hip fractures, thrombosis, and related conditions.