drugset / Trial / NCT01530399
Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery
RandomizedParallel-groupTriple-blindTreatment
Summary
The objective of this study is to determine the dose response relationship regarding blood loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid in patients undergoing primary cardiac surgery with cardiopulmonary bypass. The aim of the study is to define minimally effective dose of MDCO-2010.
Timeline
- Start
- 2012-03
- Primary completion
- 2012-11
- Completion
- 2012-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MDCO-2010 | Small molecule | 30 ug/kg | — |
| Subject | MDCO-2010 | Small molecule | 60 ug/kg | — |
| Subject | MDCO-2010 | Small molecule | 120 ug/kg | — |
| Subject | MDCO-2010 | Small molecule | 180 ug/kg | — |
| Comparator | Tranexamic Acid | Small molecule | 0.556 mg/ml | — |
| Comparator | Tranexamic Acid | Small molecule | 5 mg/kg | — |