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Also known as Certoparin
Certoparin 3, Once Daily · 5 trials · 5 indications
Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by pre-dose trough (C0,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.
Dosage regimen (3,000 o.d., 3,000 b.i.d., 8,000 o.d., 8,000 IU aXa in the morning plus 3,000 IU aXa in the evening, or 8,000 b.i.d. IU aXa) that yields a systemic total exposure to aXa (AUC0-τ,ss) in REN-patients similar to that achieved with 8,000 b.i.d. IU aXa in CON-subjects.
Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by maximum (Cmax,ss), aXa comparing REN-patients with matched CON-subjects studied in parallel.
Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by total (AUC0-τ,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.
| Arm | Type | Description |
|---|---|---|
| Certoparin | EXPERIMENTAL | - |
| Unfractionated Heparin | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | Certoparin |
| 2 | ACTIVE_COMPARATOR | Heparin |
| Certoparin control | EXPERIMENTAL | Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria. |
| Certoparin Renal | EXPERIMENTAL | Participants receive dose escalation upon medical criteria qualification at each period: Certoparin 3,000 IU once a day during period 1. Certoparin 3,000 IU twice a day during period 2. Certoparin 8,000 IU once a day during period 3. Certoparin 8,000 IU in the morning and 3,000 IU in the evening during period 4 OR Certoparin 8,000 IU twice a day during period 4. |
| Name | Type | Description |
|---|---|---|
| Certoparin | DRUG | Certoparin |
| Unfractionated Heparin | DRUG | solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily |
| Heparin | DRUG | 7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days |
| Certoparin 3,000 IU Once Daily | DRUG | Certoparin 3,000 IU subcutaneous injection once daily |
| Certoparin 3,000 IU Twice a Day | DRUG | Certoparin 3,000 IU subcutaneous injection twice a day |
| Certoparin 8,000 IU Once Daily | DRUG | Certoparin 8,000 IU subcutaneous injection once daily |
| Certoparin 8,000 IU Twice a Day | DRUG | Certoparin 8,000 IU subcutaneous injection twice a day |
Inclusion Criteria: * Patients requiring hemodialysis * Patients requiring anticoagulation therapy during hemodialysis * Written informed consent Exclusion Criteria: * Hypersensitivity to study medication * Genetic abnormality or disease of clotting system * Prior major surgery or bleeding * Othe...
Certoparin 3, Once Daily is an investigational small molecule developed by Novartis AG (ticker NVS) for cardiovascular conditions. It has been studied in thromboembolism, embolism, renal dialysis, renal insufficiency, and persistent nonvalvular atrial fibrillation. It is a low molecular weight heparin given once daily.
Certoparin 3, Once Daily has been studied for the prevention of thromboembolic events in acutely ill medical patients, for embolism, and in renal dialysis patients. It has also been evaluated in renal insufficiency and persistent nonvalvular atrial fibrillation. These uses remain investigational.
Certoparin 3, Once Daily is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical trials evaluating the drug in thromboembolism, embolism, renal dialysis, and renal insufficiency.
Certoparin 3, Once Daily has completed Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 program included a trial in acutely ill medical patients and a trial in renal dialysis patients.
Certoparin 3, Once Daily has completed four trials: NCT00451412 in thromboembolism with 3,254 patients, NCT00311753 in embolism with 342 patients, NCT01179620 in renal dialysis with 109 patients, and NCT01660295 in renal insufficiency with 32 patients. All are completed.
Yes, Certoparin 3, Once Daily is also known as Certoparin 3,000 IU Once Daily and simply Certoparin. These names refer to the same low molecular weight heparin developed by Novartis AG for cardiovascular indications.