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

AOP Orphan Pharmaceuticals AG0 个研究点目标入组 60 人开始时间: 2020年2月20日最近更新: 2021年9月7日

适应症

试验速览

暂无简介。

•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

•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

发起方