Phase 2
N=55
Cardiac Electrophysiological Study
Atrial Flutter
Bottom Line
View on ClinicalTrials.gov: NCT00616629 ↗Enrolled (actual)
55
Serious AEs
6.0%
Results posted
Sep 2011
Primary outcome: Primary: LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation)) — 11; 43; 55; 50 ms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD1305 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation)) |
11; 43; 55; 50; -10 | — |
| SECONDARY RAERP (Right Atrial Effective Refractory Period) |
19; 42; 84; 135; -12 | — |
| SECONDARY VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop) |
11; 41; 59; 65; 3 | — |
| SECONDARY QTcF (Interval From the Beginning of the Q or R Wave to the End of the T Wave in the Surface ECG, Corrected for Changes in RR Interval Using Fridericia' Formula =QT/RR1/3 Interval in Seconds) |
20; 65; 79; 65; 4 | — |
| SECONDARY Cmax Observed for AZD1305 |
0.178; 0.692; 1.46; 2.41 | — |
| SECONDARY AUC Total of AZD1305 (Umol*h/L) |
1.54; 4.97; 10.3; 17.3 | — |
| SECONDARY Number of Patients Who Had at Least One AE |
2; 2; 2; 1; 1 | — |
Summary
The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological properties and intracardiac pressures
Eligibility Criteria
Inclusion Criteria
- Patients with atrial flutter (with a ventricular rate of 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
Data sourced from ClinicalTrials.gov (NCT00616629). 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.