NCT03153072撤回2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Blood analysis of the absorption of oral amiodarone solution in a child with supraventricular tachycardia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Child who received another product under investigation or participated in another study within 60 days of the start of this study.
结局指标
主要结局
Blood analysis of the absorption of oral amiodarone solution in a child with supraventricular tachycardia
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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