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NCT03153072 | Withdrawn Phase 2

• 1 other identifier: PI2016_843_0020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Blood analysis of the absorption of oral amiodarone solution in a child with supraventricular tachycardia

  1 year

Study Arms (1)

A child with supraventricular tachycardia

OTHER

Biological: Assess the absorption of oral amiodarone

Interventions

Assess the absorption of oral amiodarone BIOLOGICAL

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

A child with supraventricular tachycardia

Eligibility Criteria

• Age: Up to 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child (boy or girl) with supra ventricular tachycardia diagnosed by ECG recording.
• Child aged 0 to 11 years.
• Child whose parents / legal representative (s) agree to sign a consent form.
• Child whose opinion / agreement has been / has been attempted to be collected.
• Child and parents / legal representative (s) being ready and able to participate in the study, understanding and committing to respect the procedures of the study throughout its duration.
• Child enrolled in a social security scheme.
• Child with a body mass index between the 3rd and the 97th percentile.

You may not qualify if:

• A child with a known hypersensitivity to the active ingredient, iodine or any of the excipients of the study formulation.
• Child who has already been treated with amiodarone (as a capsule or with the oral injectable form)
• Impossibility of taking blood samples.
• Hyperthyroidism (TSH \<laboratory low standard).
• Disruption of liver function (ASAT\> 3N and / or ALT\> 3N).
• Renal impairment (Cl creat \<30 mL / min)
• Hepatic insufficiency (TP or factor V \<70%)
• Inotropic support.
• Uncorrected severe ionic disorders.
• Extension of the QTc space before the implementation of the treatment (\> 450 ms).
• Non-paired sinus disease.
• Concomitant treatment with a drug which has an absolute contraindication with amiodarone.
• Child with gastrointestinal disorders such as malabsorption syndrome.
• Weight \<2.5 kg.
• Child whose mother was treated with amiodarone during pregnancy.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 15, 2017
• Study Start: September 6, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

FR (1)