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Pharmacokinetics of Amiodarone in Children

NCT03842020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-03-09

No results posted yet for this study

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.

Conditions

  • Heart Rhythm Disorder

Interventions

OTHER

Blood pharmacokinetic samples

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

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Marc TRELUYER, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Damien BONNET, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Sylvain RENOLLEAU, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Amelia LEHNERT, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-13
Primary Completion
2020-12-12
Completion
2020-12-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03842020 on ClinicalTrials.gov