Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Certoparin 3, Once Daily · 1 trial · 1 indication
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 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 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: * Healthy subjects OR * Subjects with severe renal insufficiency Exclusion criteria: * Hypersensitivity to study medication * Genetic abnormality or disease of clotting system * Prior major surgery or bleeding * Other protocol-defined inclusion/exclusion criteria may apply
Certoparin is an investigational small molecule being studied for cardiovascular conditions including persistent nonvalvular atrial fibrillation, thromboembolism, renal dialysis, and renal insufficiency. It is a low-molecular-weight heparin evaluated for thromboprophylaxis in acutely ill medical patients and for use in renal patients undergoing hemodialysis.
Certoparin is being developed by Novartis AG, a multinational pharmaceutical company listed on the NYSE under the ticker NVS. The drug is currently in clinical development for cardiovascular indications.
Certoparin is in Phase 3 clinical development. It has completed Phase 3 trials for persistent nonvalvular atrial fibrillation, embolism, and renal dialysis, as well as a Phase 1 pharmacokinetic study in renal insufficiency. It remains investigational and is not approved.
Certoparin has completed several clinical trials. NCT00171769, the AFFECT trial, studied it in persistent nonvalvular atrial fibrillation. NCT00311753 evaluated it for thromboprophylaxis in acutely ill medical patients with embolism. NCT01179620 tested it in renal patients undergoing hemodialysis, and NCT01660295 examined its pharmacokinetics in renal insufficiency.
Certoparin is a low-molecular-weight heparin, as indicated in the title of one of its clinical trials. It is being studied for its efficacy and safety in preventing thromboembolism in various patient populations, including those with atrial fibrillation and renal impairment.