Sponsor study identifier
interventional
9
1 country
2
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2013
Actual (reported)May 2013
Date type not reportedThis date has not been verified as actual or estimated.
May 8, 2013
Actual (reported)December 2014
Actual (reported)December 2014
Actual (reported)Pharmacokinetic profile - to demonstrate stable plasma levels
Laboratory Analysis: Plasma milrinone concentration
0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
(Heart Failure cohort) - to demonstrate evidence of haemodynamic benefit
6 hours
single oral dose of 6mg ER milrinone tablet (Part A). 1\. single intravenous infusion of milrinone (per Alfred Hospital protocol. 50ug/kg loading dose over 15 mins followed by infusion at 0.375 ug/kg/min for 6 hrs) - Part B.
single oral dose of 10 mg ER milrinone tablet (Part A) single oral dose of 10 mg ER milrinone tablet (Part B)
Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Nucleus Network
Melbourne, Victoria, 3004, Australia
9 participants (actual enrollment reported by the registry).
First Submitted
April 30, 2013
First Posted
May 8, 2013
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Goals of Care Communication
single oral dose of 14 mg ER milrinone tablet (Part A) single dose of 14 mg ER milrinone tablet 4. single oral dose of 18 mg ER milrinone tablet (if the group average plasma milrinone levels is less than 150 ug/L with 15 mg dose) - (Part B)
Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
January 14, 2015
Record last verified: 2015-01
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Source: ClinicalTrials.gov.
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