CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
Blood pharmacokinetic samplesother
Likely dose
Not stated in record
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Search/NCT03842020
NCT03842020N/ACompleted
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Population Pharmacokinetics and Pharmacodynamics of Amiodarone in Children": PK-AMIO

Assistance Publique - Hôpitaux de Paris·interventional·Posted Feb 15, 2019·Updated Mar 9, 2026

In Brief

A clinical study evaluating Blood pharmacokinetic samples for Heart Rhythm Disorder. Completed, enrolled 57 participants across 1 site.

Detailed Summary

PK-AMIO study is a population pharmacokinetic study of Amiodarone in children in order to : * study the pharmacokinetic parameters (Pop PK) of Amiodarone in children; * identify covariates explaining the variability of these pharmacokinetic parameters; * study the relationship between the concentration, the efficacy of treatment and its tolerance to optimize the use of Amiodarone in pediatrics. Indeed, there is no consensus on the optimal oral dosage in children. Few pharmacokinetic studies have been performed with only a small number of patients per study. Our study will include 70 children aged 0 to 18 years old.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Rhythm Disorder
CountriesFrance
CollaboratorsURC-CIC Paris Descartes Necker Cochin

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 15, 2019
Enrollment StartFeb 13, 2019
Primary CompletionDec 12, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.4 years ago

Interventions

Blood pharmacokinetic samplesother

1 or 3 sample(s) will be taken in the following time windows: \[H0-H3\]; \[H5-H9\] and just before the next set \[H24\], depending if the child is or is not admitted to hospital