Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD1305 · 11 trials · 4 indications
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
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.
Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.
Absolute change, after - before infusion
| 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 |
| Part A: 3 way crossover | EXPERIMENTAL | AZD1305: ER test formulation 1 (w/wo food) and reference formulation |
| Part B1: single arm | EXPERIMENTAL | AZD1305: ER test formulation 1 |
| Part B2: 3 way crossover | EXPERIMENTAL | AZD1305: ER test formulation 2 (w/wo food) and reference formulation |
| 3 | ACTIVE_COMPARATOR | Digoxin |
| A | EXPERIMENTAL | AZD1305 given as oral solution |
| B | EXPERIMENTAL | AZD1305 given as iv infusion |
| Part A: 2x2 crossover | EXPERIMENTAL | 4 different AZD1305 ER formulations |
| Part B: 3x3 crossover | EXPERIMENTAL | 2 different AZD1305 ER formulations and a reference formulation |
| 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...
AZD1305 is an investigational small molecule being studied for the treatment of atrial flutter and atrial fibrillation, as well as for evaluating left ventricle function. It is also used in healthy volunteer studies to assess the drug's properties. The drug is in Phase 2 clinical development for these cardiovascular conditions.
AZD1305 is a small molecule developed for cardiovascular conditions, but its specific molecular target has not been disclosed. The drug is being studied for its effects on atrial flutter, atrial fibrillation, and left ventricle function, though the exact mechanism of action is not publicly detailed.
AZD1305 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the drug's safety and efficacy for cardiovascular indications.
AZD1305 is in Phase 2 clinical development. It has completed six clinical trials, including Phase 1 and Phase 2 studies, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities for any indication.
AZD1305 has completed several clinical trials, including NCT00616629, a Phase 2 cardiac electrophysiological study in patients with atrial flutter, and NCT00689039, a Phase 1 study of an extended-release tablet in healthy volunteers. Other completed trials include NCT00689403 and NCT00748982, which evaluated different formulations and effects on left ventricular dysfunction.
AZD1305 is not known to have any alternative names. It is a unique investigational compound developed by AstraZeneca. No other names or aliases for this drug have been identified in the available clinical trial information.