Phase 2
Completed N=65
Explorative Study of AZD1305 in Atrial Fibrillation Patients
Source: ClinicalTrials.gov NCT00643448 ↗Enrolled (actual)
65
Serious AEs
—
Results posted
Jan 2012
Primary outcomePrimary: Maximum QTcF — 461; 427 ms
Summary
Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum QTcF |
461; 427 | — |
| SECONDARY Adverse Events (AE) |
22; 13 | — |
| SECONDARY Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state |
0.41; 0.45 | — |
| SECONDARY Compliance With Trans Telephonic Monitoring (TTM) |
97.4; 96.4; 98.3 | — |
Eligibility 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 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 ( 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
Data sourced from ClinicalTrials.gov (NCT00643448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.