drugset / Trial / NCT01849094
Evaluating the Safety, Pharmacokinetics and Haemodynamic Effect of a Slow Release Oral Formulation of Milrinone
Non-randomizedCrossoverOpen-labelTreatment
Summary
To determine the pharmacokinetic profile of a new (extended release) formulation of milrinone and to demonstrate evidence of hemodynamic effect Primary: Pharmacokinetic profile - to demonstrate stable plasma levels Secondary (HF cohort) - to demonstrate evidence of haemodynamic benefit Study Design: Open label
Timeline
- Start
- 2013-05
- Primary completion
- 2014-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Milrinone | Small molecule | 0.375 ug/kg | Oral |
| Comparator | Milrinone | Small molecule | 6 mg | Oral |
| Comparator | Milrinone | Small molecule | 10 mg | Oral |
| Comparator | Milrinone | Small molecule | 14 mg | Oral |