drugset / Trial / NCT01849094

Evaluating the Safety, Pharmacokinetics and Haemodynamic Effect of a Slow Release Oral Formulation of Milrinone

NCT01849094

Phase 1/2 Completed 9 enrolled The Alfred
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

EvaluationDrugModalityDoseRoute
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

Indications