Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Enoxaparin sodium, enoxaparin (XRP4563), Enoxaparin sodium (XRP4563)
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...