Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00915356 | Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305 | PHASE2 | COMPLETED | 228 | — | — | May 1, 2009 | Dec 1, 2009 | Feb 1, 2012 | 31 | Czechia, Denmark +6 |
| NCT00643448 | Explorative Study of AZD1305 in Atrial Fibrillation Patients | PHASE2 | COMPLETED | 65 | — | — | Mar 1, 2008 | Aug 1, 2008 | Jan 26, 2012 | 18 | Denmark, Norway +4 |
| NCT00712465 | An Interaction Study With Digoxin and AZD1305 | PHASE1 | COMPLETED | 18 | — | — | Aug 1, 2008 | Nov 1, 2008 | Dec 3, 2010 | 1 | Sweden |
QTcF-QT interval corrected for the RR interval (the time elapsing between two consecutive R waves in the electrocardiogram (ECG)) using the Fridericia formula.For each of 3 consecutive beats (5 consecutive beats if AF) a manual measurement, preferably in lead V2, of QTend intervals was done.The mean QT values of the 3 consecutive beats (5 consecutive beats if AF) were, together with RR intervals, date \& time of the ECG, entered into the eCase Report Form (eCRF).The selected beats had to be marked with calipers and noted together with measured values and calculations on the print-out and signed
Conversion of AF to SR with maintenance of SR maintained for at least 1 minute
Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | AZD1305 iv infusion |
| 2 | PLACEBO_COMPARATOR | Placebo iv infusion |
| AZD1305 loading dose 250 mg + 125 mg | EXPERIMENTAL | Tablets |
| AZD1305 loading dose 500 mg + placebo | EXPERIMENTAL | Tablets |
| Placebo corresponding to AZD1305 loading dose | PLACEBO_COMPARATOR | Tablets |
| 3 | ACTIVE_COMPARATOR | Digoxin |
| Name | Type | Description |
|---|---|---|
| AZD1305 | DRUG | Intravenous (iv) single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes |
| Placebo | DRUG | iv single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes |
| Digoxin | DRUG | Tablet, repeated administration |
Inclusion Criteria: * Clinical indication for cardioversion of Atrial Fibrillation, ie a correction of irregular heart rhythm to normal heart rhythm * Current episode of Atrial Fibrillation (ie irregular heart rhythm) lasting up to 3 months at randomisation * Adequate anticoagulation according to i...