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Evaluation of the Pharmacokinetic Profile, Pharmacodynamic Effects, Acceptability and Tolerability of an Oral Amiodarone Solution of 15 mg / mL in Children With Supra Ventricular Tachycardia

NCT03153072 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-05-15

No results posted yet for this study

Summary

The supra ventricular tachycardia is the most common symptomatic arrhythmia in pediatrics. Amiodarone is an antiarrhythmic drug used in this indication. Pharmacokinetic, efficacy and safety data are not known in the pediatric population due to the lack of a suitable specialty available on the market.

The development of an amiodarone oral solution formulation adapted to this age group should provide a therapeutic alternative and collect data on the pharmacokinetics, efficacy, acceptability and tolerability of the drug.

Conditions

  • Supraventricular Tachycardia

Interventions

BIOLOGICAL

Assess the absorption of oral amiodarone

Evaluate the pharmacokinetics of oral amiodarone solution at 15 mg / mL after oral administration

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-06
Primary Completion
2017-03-01
Completion
2017-03-01

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 NCT03153072 on ClinicalTrials.gov