drugset / Trial / NCT03551730
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.
Timeline
- Start
- 2012-12
- Primary completion
- 2015-09
- Completion
- 2015-09
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Module 3 (210 mg Bolus) Original; p <0.0001; Least Squares Means (Difference) -0.23; ANCOVA NCT03551730 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Andexanet alfa | Protein / enzyme biologic | 210 mg | Intravenous |
| Subject | Andexanet alfa | Protein / enzyme biologic | 420 mg | Intravenous |
| Background | Enoxaparin sodium | Other / unclassified | — | — |
Indications
No indication recorded.