Status:
COMPLETED
Explorative Study of AZD1305 in Atrial Fibrillation Patients
Lead Sponsor:
AstraZeneca
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state
Eligibility Criteria
Inclusion
- Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28 days.
- Sinus rhythm at randomisation
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00643448
Start Date
March 1 2008
End Date
August 1 2008
Last Update
January 26 2012
Active Locations (18)
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1
Research Site
Aalborg, Denmark
2
Research Site
Copenhagen, Denmark
3
Research Site
Esbjerg, Denmark
4
Research Site
Hvidovre, Denmark