study to investigate pharmacodynamics, pharmacokinetic, safety and tolerability study of intravenous infusion of Landiolol hydrochloride (AOP LDLL600) in 20 Caucasian patients with tachycardic atrial fibrillation (AF) or atrial flutter (AFL) treated either according to 'Alternative' or 'Conventional' dosing scheme with a pilot phase and a planned randomized phase

• Conditions: 20 Caucasian patients with tachycardic atrial fibrillation (AF) or atrial flutter (AFL); MedDRA version: 18.1Level: LLTClassification code 10003663Term: Atrial flutter/ fibrillationSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-001905-42-AT
• Lead Sponsor: AOP Oprhan Pharmaceuticals AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-06
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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:
1. SBP <100 mmHg (measured with an automatic device in supine position)
2. Sick sinus syndrome, AV block 2nd or 3rd degree
3. Preexcitation syndromes
4. Ventricular rate >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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints:<br>1.Frequency of pts with successful HR control at any measurement time point<br>2.Frequency of pts with successful HR control achieved during first 16 min (including) after<br> continuous infusion start and maintained up to infusion end<br>3.Frequency of pts with successful HR control 60 min after continuous IMP infusion end<br>4.Frequency of pts who converted to sinus rhythm evaluated at any measurement time point <br>5.Time to successful HR control <br>6.Time to conversion to sinus rhythm <br>7.Incidence and severity/seriousness of adverse events<br>8.Local tolerability over study course<br>9.Average dose applied over course of the study and dose applied at each time-point<br>10.Time-points when dose adjustment or infusion discontinuation is requested and dose administered at this time-points<br>11.Pharmacokinetic parameters<br>12.ECG parameters<br>13.BP parameters <br>;Timepoint(s) of evaluation of this end point: 24 hours