Study to investigate the effectiveness and safety of AOP Landiolol in controlling supraventricular tachycardia in children.

Phase 1

• Conditions: Supraventricular tachycardia in pediatric patients.; MedDRA version: 20.0Level: LLTClassification code 10003859Term: AV reentrant tachycardiaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10074640Term: Junctional ectopic tachycardiaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10042604Term: Supraventricular tachycardiaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: LLTClassification code 10052350Term: Multifocal atrial tachycardiaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10003662Term: Atrial flutterSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10040752Term: Sinus tachycardiaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: LLTClassification code 10003857Term: AV nodal reentrant tachycardiaSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-001129-17-LT
• Lead Sponsor: AOP Orphan Pharmaceuticals AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-20
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Landiolol in the pediatric population.;Secondary Objective: - Controlling supraventricular tachyarrhythmias in the pediatric population.<br>- Assessment of safety of LDLL300 in the pediatric population.<br>- Dose-response assessment for LDLL300 in the pediatric population.<br>;Primary end point(s): Percentage of patients converting to normal sinus rhythm (cardioversion) within 3.5 hours (210 min) of the commencement of the IMP infusion.;Timepoint(s) of evaluation of this end point: 3.5 hours (210 min)