Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01660295 | Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects | PHASE1 | COMPLETED | 32 | — | — | Dec 1, 2011 | - | Aug 8, 2012 | 1 | Hungary |
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