| Primary | Dose-response Relationship for QTcF Interval of AZD1305 | 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 | | Posted | | Mean | 95% Confidence Interval | ms | | At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion). | | | | ID | Title | Description |
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| OG000 | AZD1305 Dose Group 1 | AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h. | | OG001 | AZD1305 Dose Group 2 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h. | | OG002 | AZD1305 Dose Group 3 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h. | | OG003 | AZD1305 Dose Group 4 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h. | | OG004 | Placebo | Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h. |
| | Units | Counts |
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| Participants | - OG00025
- OG00145
- OG00245
- OG003
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| | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000461(449 to 474)
- OG001486(476 to 495)
- OG002490(480 to 499)
- OG003
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| |
| Primary | Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR) | Conversion of AF to SR with maintenance of SR maintained for at least 1 minute | | Posted | | Number | 95% Confidence Interval | Percentage of patients converted to SR | | Within 90 minutes from start of infusion | | | | ID | Title | Description |
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| OG000 | AZD1305 Dose Group 1 | AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h. | | OG001 | AZD1305 Dose Group 2 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h. | | OG002 | AZD1305 Dose Group 3 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h. | | OG003 | AZD1305 Dose Group 4 | |
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| Secondary | Wide QRS Tachycardias | Number of patients with wide QRS tachycardias, determined as significant arrhythmias by an Adjudication Committee (AC). The AC analysed and classified the occurrence of significant arrhythmias (other than AF or AFl) and pauses based on the 12-lead Holter reports. All pauses (≥3 sec) and all wide QRS complex tachycardias (≥3 beats, QRS ≥120 ms, and ≥120 bpm). | | Posted | | Number | | Participants | | From start of study drug infusion until discharge from hospital on study day 2. | | | | ID | Title | Description |
|---|
| OG000 | AZD1305 Dose Group 1 | AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h. | | OG001 | AZD1305 Dose Group 2 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h. | | OG002 | AZD1305 Dose Group 3 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h. |
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| Secondary | Heart Rhythm. Number of Participants With Early Relapse Into AF. | Early relapse into AF within 5 minutes from obtaining the defined criterion for conversion to SR (i.e.1 minute in SR). Patients never converted are not included in the analysis. | | Posted | | Number | | Participants | | Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR | | | | ID | Title | Description |
|---|
| OG000 | AZD1305 Dose Group 1 | AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h. | | OG001 | AZD1305 Dose Group 2 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h. | | OG002 | AZD1305 Dose Group 3 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h. | | OG003 |
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| Secondary | Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion | | | Posted | | Number | | Participants | | During 24 hours following start of study drug infusion | | | | ID | Title | Description |
|---|
| OG000 | AZD1305 Dose Group 1 | AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h. | | OG001 | AZD1305 Dose Group 2 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h. | | OG002 | AZD1305 Dose Group 3 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h. | | OG003 | AZD1305 Dose Group 4 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h. |
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| Secondary | Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion. | Number of patients in SR at day 13-18 | | Posted | | Number | | Participants | | During 13 to 18 days following study drug infusion | | | | ID | Title | Description |
|---|
| OG000 | AZD1305 Dose Group 1 | AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h. | | OG001 | AZD1305 Dose Group 2 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h. | | OG002 | AZD1305 Dose Group 3 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h. | | OG003 | AZD1305 Dose Group 4 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h. |
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| Secondary | Study the Relationship Between Systemic Exposure and Response, With Special Regards to Conversion of AF to SR and the Effect on the QTcF Interval. | | | Not Posted | | | | | | Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted. | | | | | | |
| Secondary | Maximal Observed Plasma Concentration of AZD1305 | Plasma concentration of AZD1305 | | Posted | | Median | Full Range | mol/L | | Up to 24 hours following start of study drug infusion | | | | ID | Title | Description |
|---|
| OG000 | AZD1305 Dose Group 1 | AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h. | | OG001 | AZD1305 Dose Group 2 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h. | | OG002 | AZD1305 Dose Group 3 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h. | | OG003 | AZD1305 Dose Group 4 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h. |
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| Secondary | Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 10 Hours to 7 Days | | | Posted | | Number | | Participants | | Conversion from AF to SR within 90 minutes from start of infusion | | | | ID | Title | Description |
|---|
| OG000 | AZD1305 Dose Group 1 | AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h. | | OG001 | AZD1305 Dose Group 2 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h. | | OG002 | AZD1305 Dose Group 3 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h. | | OG003 | AZD1305 Dose Group 4 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h. |
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| Secondary | Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 8 Days - 30 Days. | Subgroup analysis for patients with duration of current AF episode 8 days - 30 days. Number of patients converting from AF to SR. | | Posted | | Number | | Participants | | Conversion from AF to SR within 90 minutes from start of infusion | | | | ID | Title | Description |
|---|
| OG000 | AZD1305 Dose Group 1 | AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h. | | OG001 | AZD1305 Dose Group 2 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h. | | OG002 | AZD1305 Dose Group 3 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h. | | OG003 | AZD1305 Dose Group 4 |
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| Secondary | Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months | Subgroup analysis for patients with duration of current AF episode 31 days - 3 months. Number of patients converting from AF to SR. | | Posted | | Number | | Participants | | Conversion from AF to SR within 90 minutes from start of infusion | | | | ID | Title | Description |
|---|
| OG000 | AZD1305 Dose Group 1 | AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h. | | OG001 | AZD1305 Dose Group 2 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h. | | OG002 | AZD1305 Dose Group 3 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h. | | OG003 | AZD1305 Dose Group 4 |
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| Secondary | Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion | Percentage, with 95% confidence interval, of patients with QTcF≤500 ms six hours following start of study drug infusion | | Posted | | Number | 95% Confidence Interval | Percent of participants | | Six hours following start of study drug infusion | | | | ID | Title | Description |
|---|
| OG000 | AZD1305 Dose Group 1 | AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h. | | OG001 | AZD1305 Dose Group 2 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h. | | OG002 | AZD1305 Dose Group 3 | AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h. | | OG003 | AZD1305 Dose Group 4 |
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