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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01535222 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery | PHASE2 | COMPLETED | 32 | — | — | Nov 1, 2010 | Jun 1, 2011 | Jul 19, 2012 | - | — |
Number of patients experiencing Adverse Events
Number of patients experiencing Serious Adverse Events
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 3 patients: loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg |
| Cohort 2 | EXPERIMENTAL | 3 pts: loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg |
| Cohort 3 | EXPERIMENTAL | 6 patients: loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg |
| Cohort 4 | EXPERIMENTAL | 6 patients: loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg |
| Cohort 5 | EXPERIMENTAL | 6 patients: loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg |
| Placebo | PLACEBO_COMPARATOR | 8 patients: commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion |
| Name | Type | Description |
|---|---|---|
| MDCO-2010 | DRUG | MDCO-2010 solution for infusion. Dosage: Pump priming dose; Loading dose infusion over 6 minutes; Maintenance infusion for duration of surgery |
| Placebo | DRUG | Commercially available NaCl |
Inclusion Criteria * Men, aged 18 to 80 years or * Post-menopausal women, aged up to 80 years. Postmenopausal status defined as ≥ 1 year since last menstruation in women with no medical history of hysterectomy or women with a medical history of bilateral oophorectomy * Planned elective, isolated pr...