EUCTR2015-001129-17-DE进行中（未招募）1 期
A multicenter, open-label study to investigate the effectiveness and safety of AOP Landiolol in controlling supraventricular tachycardia in pediatric patients (LANDI-PED). - LANDI-PED
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Informed consent/assent from parents/legal representative(s) and children, if applicable.
- •2. Age: from birth to the day before the 18th birthday.
- •3. Body weight at least 2.5 kg.
- •4. Sustained supraventricular tachyarrhythmia for more than 1 min.
- •5. If sub-type, paroxysmal supraventricular tachycardia (AVRT, AVNRT), refractory to treatment with adenosine, adenosine treatment relapsers and patients with contraindications to adenosine; or other forms of paroxysmal SVT not indicated for adenosine.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Acute cardiogenic shock.
- •2. Severe, uncorrectable metabolic acidosis.
- •3. Ventricular tachycardia.
- •4. Sick sinus syndrome (if there is no possibility for cardiac pacing) or clinically significant bradycardia.
- •5. Acute asthma.
- •6. Known pulmonary hypertension
- •7. Known stage 4 and 5 chronic renal disease (Table 7).
- •8. AV block 2nd or 3rd degree (if there is no possibility for cardiac pacing).
- •9. Clinically significant hypotension.
- •10. Postmenstrual age (gestational age + chronological age) <37 weeks
- •11. Untreated pheochromocytoma.
- •12. End-stage disease.
- •13. Pregnant or breast feeding patients.
- •14. Known hypersensitivity to any component of the study medication (e.g. Landiolol, mannitol).
- •15. Participation in a clinical study or exposure to any study medication within 28 days before LDLL300 infusion start, with the exception of LDLL300 (end-of-study visit completed).
- •16. Decompensated heart failure
研究者
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