EUCTR2015-001129-17-LT
Active, not recruiting
Phase 1
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
ConditionsSupraventricular tachycardia in pediatric patients.MedDRA version: 20.0Level: LLTClassification code 10003859Term: AV reentrant tachycardiaSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10074640Term: Junctional ectopic tachycardiaSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10042604Term: Supraventricular tachycardiaSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: LLTClassification code 10052350Term: Multifocal atrial tachycardiaSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10003662Term: Atrial flutterSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10040752Term: Sinus tachycardiaSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: LLTClassification code 10003857Term: AV nodal reentrant tachycardiaSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Supraventricular tachycardia in pediatric patients.
- Sponsor
- AOP Orphan Pharmaceuticals AG
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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