Supraventricular tachycardia in pediatric patients. MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10074640 Term: Junctional ectopic tachycardia System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10042604 Term: Supraventricular tachycardia System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.
Conditions
Interventions
Trade Name: RAPIBLOC 300 mg
Product Name: RAPIBLOC (Landiolol hydrochloride lyophilized powder 300 mg/50 ml)
Product Code: LDLL300
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: Landio
Sponsors
AOP Orphan Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile of LDLL300 in the pediatric population.;Secondary Objective: - Controlling supraventricular tachyarrhythmias in the pediatric population. - Assessment of safety of LDLL300 in the pediatric population. - Dose-response assessment for LDLL300 in the pediatric population. ;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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Relative and cumulative improvement rates (at least 20% reduction from baseline HR) at each dosing level (before increase of treatment dose). - Relative and cumulative non-response* rates at each dosing level. - Percent change in HR from baseline at each time point. - Relationship between change in heart rate from baseline and patient’s age. - Percentage of patients showing sustained restoration of sinus rhythm for more than 24 hours and 1 week after LDLL300 infusion end. - Percentage of patients for whom the infusion period was prolonged and duration of prolongation. - Percentage of patients achieving either SR conversion or HR control at any time during the prolongation period. - Time from start of LDLL300 infusion until 20% reduction of HR is achieved. - Time from start of LDLL300 infusion until conversion to normal sinus rhythm is achieved. *Non-responders” are treated patients who have no HR response (= 20% reduction of HR from baseline) and/or no conversion to normal sinus rhythm. Secondary pharmacokinetics endpoints: - PK variables including at least t1/2, AUC, volume of distribution, and total body clearance will be calculated using concentration collected during and after LDLL300 infusion end. Secondary safety endpoints: - Incidence and severity/seriousness of adverse events (AE). - Need for LDLL300 infusion end or dose reduction due to safety reasons (i.e. percentage of patients requiring LDLL300 infusion end or dose reduction due to AE(s) related to IMP). ;Timepoint(s) of evaluation of this end point: 1 week, 24 hrs | — |
Countries
Austria, Germany, Hungary, Lithuania, Spain
Contacts
Public ContactClinical Operations
AOP Orphan Pharmaceuticals GmbH
Outcome results
None listed