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Also known as OTAMIXABAN (XRP0673), XRP0673
OTAMIXABAN · 4 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion | EXPERIMENTAL | From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide) |
| Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion | EXPERIMENTAL | From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide) |
| UFH + Eptifibatide | ACTIVE_COMPARATOR | From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Placebo (for Otamixaban) * Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion) |
| Otamixaban Dose 1 | EXPERIMENTAL | dosage regimen 1 |
| Otamixaban Dose 2 | EXPERIMENTAL | dosage regimen 2 |
| Otamixaban Dose 3 | EXPERIMENTAL | dosage regimen 3 |
| Otamixaban Dose 4 | EXPERIMENTAL | dosage regimen 4 |
| Otamixaban Dose 5 | EXPERIMENTAL | dosage regimen 5 |
| UFH/Eptifibatide | ACTIVE_COMPARATOR | - |
| Severe renal impairment population | EXPERIMENTAL | - |
| Moderate renal impairment population | EXPERIMENTAL | - |
| Mild renal impairment population | EXPERIMENTAL | - |
| Healthy population | EXPERIMENTAL | Healthy matched subjects |
| Name | Type | Description |
|---|---|---|
| Otamixaban | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Placebo (for Otamixaban) | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| UFH | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Placebo (for UFH) | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Eptifibatide | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Placebo (for Eptifibatide) | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Otamixaban (XRP0673) | DRUG | intravenous administration |
| unfractionated heparin | DRUG | intravenous administration |
| Percutaneous Coronary Intervention | PROCEDURE | - |
Inclusion criteria: Patient with non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS) with: 1. Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization, AND 2. One of the two following criteria: * New ST-segment depression ≥ 0.1 mV (≥1 mm), ...
Otamixaban was developed for acute coronary syndrome, including unstable angina and non-ST elevation myocardial infarction, and for patients undergoing percutaneous coronary intervention. It was also studied in patients with renal impairment. It is an investigational anticoagulant and is not approved for use.
Otamixaban targets factor Xa (F10). It is a direct inhibitor of this coagulation enzyme, which is involved in the blood clotting cascade. By inhibiting factor Xa, otamixaban was designed to reduce thrombin generation and prevent clot formation during acute coronary events.
Otamixaban was developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the clinical trials evaluating the drug in acute coronary syndrome and related conditions.
Otamixaban reached Phase 3 development. The Phase 3 trial was completed, but the drug is not approved and remains investigational. No active trials are currently listed.
Otamixaban has been studied in several completed trials, including the Phase 3 trial NCT01076764 in acute coronary syndrome, the Phase 2 trial NCT00317395 in non-ST elevation acute coronary syndrome, the Phase 2 SEPIA-PCI trial NCT00133731, and the Phase 1 renal impairment study NCT01120314.
Yes, otamixaban is also known as XRP0673. These names refer to the same investigational factor Xa inhibitor developed by Sanofi.