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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00311090 | Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs | PHASE3 | COMPLETED | 757 | — | — | Apr 1, 2006 | Jan 1, 2008 | Mar 21, 2016 | 20 | United States, Argentina +18 |
| Arm | Type | Description |
|---|---|---|
| Idrabiotaparinux | EXPERIMENTAL | Idrabiotaparinux sodium , 3.0 mg, once-weekly for 6 months. In avidin sub-study, participants receive on Day 183, avidin 100 mg or placebo (for avidin) (4 hours after Idrabiotaparinux administration) |
| Idraparinux | ACTIVE_COMPARATOR | Idraparinux sodium, 2.5 mg, once-weekly for 6 months In avidin sub-study, participants receive on Day 183, placebo (for avidin) (4 hours after Idrabiotaparinux administration) |
| Name | Type | Description |
|---|---|---|
| Idrabiotaparinux sodium | DRUG | 0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection |
| Idraparinux sodium | DRUG | 0.5 mL pre-filled syringe for 2.5 mg Subcutaneous injection |
| Avidin | DRUG | 100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes |
| Placebo (for Avidin) | DRUG | Avidin matching powder in 10 mg/mL solution Intravenous infusion for 30 minutes |
Inclusion Criteria: * Confirmed acute symptomatic DVT of the lower limbs Exclusion Criteria: * Severe concomitant diseases (e.g. renal failure, hepatic failure, uncontrolled hypertension) * Active bleeding or high risk for bleeding. * Pregnancy or childbearing potential without proper contracepti...