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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001716-59 | EudraCT Number |
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Medical Products Agency
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | A single dose of AZD2927 administered as an iv infusion |
|
| 2 | Placebo Comparator | A single dose of placebo administered as an iv infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2927 | Drug | A single dose of AZD2927 administered as an iv infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Left Atrial Effective Refractory Period | Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion | Baseline to last assessment during IP infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular Effective Refractory Period | Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion | Baseline to last assessment during IP infusion |
| Paced QT Interval |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan C Carlsson, MD, PHD | AstraZeneca | Study Director |
| Hakan Walfridsson, MD, PHD | University Hospital Linkoping Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Oslo | Norway | ||||
| Research Site |
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The study had enrolled 20 patients. A total of 18 patients were randomised of which 12 patients received AZD2927. All patients who received treatment completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD2927 | AZD2927 solution for infusion |
| FG001 | PLACEBO | Placebo solution for infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD2927 | AZD2927 solution for infusion |
| BG001 | PLACEBO | Placebo solution for infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Left Atrial Effective Refractory Period | Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion | Full A analysis Set (FAS) | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD2927 | AZD2927 solution for infusion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000603099 | AZD2927 |
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| Placebo |
| Drug |
A single dose of placebo administered as an iv infusion |
|
Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements
| Baseline to last assessment during IP infusion |
| Atrio-ventricular Effective Refractory Period | Change from observation before IP infusion to during 1st and 2nd LAERP Mean | Baseline to last assessment during IP infusion |
| PA Interval | Reflects intra-atrial conduction and is defined as the interval from the onset of the P wave in the surface ECG to the onset of atrial activation (A) in the His bundle electrogram. Change from observation before IP infusion to 30 min after IP start | Baseline to last assessment during IP infusion |
| AH Interval | Change from observation before IP infusion to 30 mins after IP start. AH interval- the conduction time from the low right atrium at the inter-atrial septum through the AV node to the His bundle, ie, intra-nodal conduction time. | Baseline to last assessment during IP infusion |
| HV Interval | Change from observation before IP infusion to 30 mins after IP start. HV interval - represents conduction time from the proximal His bundle to the ventricular myocardium, ie, infra-nodal conduction time. | Baseline to last assessment during IP infusion |
| PR Interval | Interval from the onset of the P-wave to the start of the QRS complex. Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion | Baseline to last assessment during IP infusion |
| QRS Duration | Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion | Baseline to last assessment during IP infusion |
| RR Interval | Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion | Baseline to last assessment during IP infusion |
| Linköping |
| Sweden |
| Research Site | Örebro | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Umeå | Sweden |
| BG002 |
| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Ventricular Effective Refractory Period | Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion | FAS | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
|
|
| Secondary | Paced QT Interval | Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements | FAS | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
|
|
| Secondary | Atrio-ventricular Effective Refractory Period | Change from observation before IP infusion to during 1st and 2nd LAERP Mean | FAS | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
|
|
| Secondary | PA Interval | Reflects intra-atrial conduction and is defined as the interval from the onset of the P wave in the surface ECG to the onset of atrial activation (A) in the His bundle electrogram. Change from observation before IP infusion to 30 min after IP start | FAS | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
|
|
| Secondary | AH Interval | Change from observation before IP infusion to 30 mins after IP start. AH interval- the conduction time from the low right atrium at the inter-atrial septum through the AV node to the His bundle, ie, intra-nodal conduction time. | FAS | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
|
|
| Secondary | HV Interval | Change from observation before IP infusion to 30 mins after IP start. HV interval - represents conduction time from the proximal His bundle to the ventricular myocardium, ie, infra-nodal conduction time. | FAS | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
|
|
| Secondary | PR Interval | Interval from the onset of the P-wave to the start of the QRS complex. Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion | FAS | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
|
|
| Secondary | QRS Duration | Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion | FAS | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
|
|
| Secondary | RR Interval | Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion | FAS | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
|
|
| Primary | Left Atrial Effective Refractory Period | Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion | Per Protocol (PP) | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
|
|
| Secondary | Ventricular Effective Refractory Period | Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion | PP | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
|
|
| Secondary | Paced QT Interval | Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements | PP | Posted | Mean | Standard Deviation | msec | Baseline to last assessment during IP infusion |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | PLACEBO | Placebo solution for infusion | 0 | 6 | 1 | 6 |
| Atrial Flutter | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| MEDICAL DEVICE COMPLICATION | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
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