20 Caucasian patients with tachycardic atrial fibrillation (AF) or atrial flutter (AFL) MedDRA version: 18.1 Level: LLT Classification code 10003663 Term: Atrial flutter/ fibrillation System Organ Class: 100000004849
Conditions
Interventions
Product Name: Landiolol hydrochloride lyophillized powder 600mg/50ml
Product Code: LDLL600
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: Landiolol Hydrochloride
CAS Number: 144481-98-1
Sponsors
AOP Oprhan Pharmaceuticals AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. AF or AFL with ventricular rate between =100-200bpm/minute and clinical symptoms (including but not limited to palpitations, irregular pulse, fatigue, rapid heart beat, shortness of breath, dizziness, sweating) 2. SBP = 100 mmHg 3. Able and willing to give informed consent 4. Age =18 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. SBP 200/min 5. Acute coronary syndrome subjected to intervention (unstable angina, myocardial infarction) 6. NYHA III and IV 7. Cardiogenic shock or heart failure requiring inotropic agents or intubaiton 8. Respiratory failure requiring intubation 9. Pregnant or breast feeding patients 10. History of hypersensitivity to any component of the study drug (e.g. landiolol, mannitol) 11. Untreated pheochromocytoma 12. Bronchospasm or asthma 13. Ketoacidosis 14. End stage disease 15. Inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to study PD of LDLL600 in Caucasian patients (pts) with tachycardic AF or AFL treated either according to "Alternative" or "Conventional" dosing scheme;Secondary Objective: to study tolerability, safety and PK of the "Alternative" and "Conventional" LDLL600 dosing scheme in Caucasian pts with AF or AFL;Timepoint(s) of evaluation of this end point: 24 hours;Primary end point(s): Primary endpoint is frequency of pts with successful HR control achieved and maintained during first 16 min (including) after continious IMP infusion start in one or the other dosage Group. Successful HR control is defined as achieving of HR <90 bpm or =20% reduction of HR from baseline (i.e. the last HR value available before IMP administration). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: 1. Frequency of pts with successful HR control at any measurement time point 2. Frequency of pts with successful HR control achieved during first 16 min (including) after continuous infusion start and maintained up to infusion end 3. Frequency of pts with successful HR control 60 min after continuous IMP infusion end 4. Frequency of pts who converted to sinus rhythm evaluated at any measurement time point 5. Time to successful HR control 6. Time to conversion to sinus rhythm 7. Incidence and severity/seriousness of adverse events 8. Local tolerability over study course 9. Average dose applied over course of the study and dose applied at each time-point 10. Time-points when dose adjustment or infusion discontinuation is requested and dose administered at this time-points 11. Pharmacokinetic parameters 12. ECG parameters 13. BP parameters ;Timepoint(s) of evaluation of this end point: 24 hours | — |
Countries
Austria
Contacts
Public ContactSponsor
AOP Orphan Pharmaceuticals AG
Outcome results
None listed