NCT03153072

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 11 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
BIOLOGICAL	Assess the absorption of oral amiodarone	Evaluate the pharmacokinetics of oral amiodarone solution at 15 mg / mL after oral administration

Timeline

• Start date: 2016-09-06
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2017-05-15
• Last updated: 2017-05-15

Locations

1 site across 1 country: France