Explorative Study of AZD1305 in Atrial Fibrillation Patients

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28 days.

• Sinus rhythm at randomisation

Exclusion Criteria:

• Haemodynamically unstable condition as judged by the Investigator, systolic BP <100 mmHg or >180 mmHg, or diastolic BP >105 mmHg at randomisation

• Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia (PVT), sustained ventricular tachycardia, long QT syndrome and/or Brugada syndrome

• Sinus bradycardia (<50 beats per minute (bpm)) at randomisation

• QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation,

• Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L

• QRS duration >120 ms at randomisation

• Use of any antiarrhythmic drug class I and/or III, digitalis glycoside, QT prolonging drug and/or drug that inhibits CYP3A4, as well as St John's Worth