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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-0003455-36 (EudraCT No) |
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The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological properties and intracardiac pressures
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1305 | Drug | Intravenous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation)) | Absolute change, after - before infusion | Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product |
| Measure | Description | Time Frame |
|---|---|---|
| RAERP (Right Atrial Effective Refractory Period) | Absolute change, after - before infusion | Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product |
| VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauri Toivonen, MD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aalborg | Denmark | ||||
| Research Site |
At the pre-entry visit, which took place within 14 days before the planned catheter ablation (Study Day), patients underwent a full clinical assessment including a physical examination, ECG recording, Bood pressure(BP)/heart rate measurement, routine laboratory tests, and transthoracic echocardiography (TTE, if not done within the prior 6 months).
A total of 68 patients were enrolled into the study. The study randomised 55 patients and 50 of those patients received study drug. All patients who received study drug completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD1305 Dose Group 1 | Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h |
| FG001 | AZD1305 Dose Group 2 | Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h |
| FG002 | AZD1305 Dose Group 3 | Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h |
| FG003 | AZD1305 Dose Group 4 | Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h |
| FG004 | Placebo | Corresponding placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD1305 Dose Group 1 | Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h |
| BG001 | AZD1305 Dose Group 2 | Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h |
| 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 | LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation)) | Absolute change, after - before infusion | Posted | Mean | Full Range | ms | Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product |
|
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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 | AZD1305 Dose Group 1 | Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia And Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C550721 | tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate |
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Absolute change, after - before infusion |
| Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product |
| 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) | Absolute change, after - before infusion | Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product. ECG measurements, including QTcF, are available from several additiona |
| Cmax Observed for AZD1305 | A total of 13 scheduled PK samples for each patient during and after infusion | During and after infusion |
| AUC Total of AZD1305 (Umol*h/L) | A total of 13 scheduled PK samples for each patient during and after infusion | Based on PK samples during and after infusion |
| Number of Patients Who Had at Least One AE | Number of patients | During active treatment period |
| Aarhus |
| Denmark |
| Research Site | Copenhagen | Denmark |
| Research Site | Hellerup | Denmark |
| Research Site | Helsinki | Finland |
| Research Site | Kuopio | Finland |
| Research Site | Oulu | Finland |
| Research Site | Bergen | Norway |
| Research Site | Oslo | Norway |
| Research Site | Gŏteborg | Sweden |
| Research Site | Linkŏping | Sweden |
| Research Site | Ŏrebro | Sweden |
| Research Site | Umeå | Sweden |
| AV-block |
|
| BG002 | AZD1305 Dose Group 3 | Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h |
| BG003 | AZD1305 Dose Group 4 | Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h |
| BG004 | Placebo | Corresponding placebo |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | AZD1305 Dose Group 3 | Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h |
| OG003 | AZD1305 Dose Group 4 | Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h |
| OG004 | Placebo | Corresponding placebo |
|
|
| Secondary | RAERP (Right Atrial Effective Refractory Period) | Absolute change, after - before infusion | Posted | Mean | Full Range | ms | Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product |
|
|
|
| Secondary | VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop) | Absolute change, after - before infusion | Posted | Mean | Full Range | ms | Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product |
|
|
|
| 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) | Absolute change, after - before infusion | Posted | Mean | Full Range | ms | Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product. ECG measurements, including QTcF, are available from several additiona |
|
|
|
| Secondary | Cmax Observed for AZD1305 | A total of 13 scheduled PK samples for each patient during and after infusion | Posted | Mean | Full Range | umol/L | During and after infusion |
|
|
|
| Secondary | AUC Total of AZD1305 (Umol*h/L) | A total of 13 scheduled PK samples for each patient during and after infusion | Posted | Mean | Full Range | umol*h/L | Based on PK samples during and after infusion |
|
|
|
| Secondary | Number of Patients Who Had at Least One AE | Number of patients | Posted | Number | Participants | During active treatment period |
|
|
|
| 0 |
| 11 |
| 2 |
| EG001 | AZD1305 Dose Group 2 | Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h | 1 | 12 | 1 |
| EG002 | AZD1305 Dose Group 3 | Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h | 1 | 13 | 1 |
| EG003 | AZD1305 Dose Group 4 | Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h | 0 | 2 | 1 |
| EG004 | Placebo | Corresponding placebo | 1 | 12 | 0 |
| Muscoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope Vasovagal | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |