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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007058-79 |
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Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1305 | Drug | AZD1305 loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum QTcF | Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10. | During treatment days 2-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) | Number of patients who had at least one AE according to the definition in the study protocol | During treatment days 2-10 |
| Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Egstrup | Svendborg Sygehus, Forsknings-og udviklingsafd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aalborg | Denmark | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21619383 | Derived | Egstrup K, Bergfeldt L, Duris T, Gullestad L, Kochmanski M, Kusnierz B, Nielsen T, Sawicki S, Aunes-Jansson M, Edvardsson N, Frison L, Johansson S, Berggren A. QT response after a test dose and during maintenance therapy with AZD1305 in patients with atrial fibrillation: a double-blind, randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2011 Jun 1;11(3):199-208. doi: 10.2165/11591750-000000000-00000. |
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All patients will attend a pre-entry Visit 3-28 days before the planned randomisation. At this Visit, the Investigator ensures that a signed Informed Consent Form has been obtained before any study specific procedures are conducted. Patients who have given their consent to participate in the study will then undergo a full clinical assessment
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD1305 Group A | AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 |
| FG001 | AZD1305 Group B | AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 |
| FG002 | Placebo | Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD1305 Group A | AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 |
| BG001 | AZD1305 Group B | AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 |
| 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 | Maximum QTcF | Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10. | Posted | Mean | Full Range | ms | During treatment days 2-10 |
|
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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 Group A | AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular Bigeminy | Cardiac 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 |
|---|---|
| D001281 | Atrial Fibrillation |
| 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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| AZD1305 | Drug | AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 |
|
| Placebo | Drug | Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2 |
|
Population PK model parameter estimates derived from plasma concentrations of AZD1305
| During treatment days 1-10 |
| Compliance With Trans Telephonic Monitoring (TTM) | Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis | During treatment days 1-10 |
| Copenhagen |
| Denmark |
| Research Site | Esbjerg | Denmark |
| Research Site | Hvidovre | Denmark |
| Research Site | Silkeborg | Denmark |
| Research Site | Svendborg | Denmark |
| Research Site | Oslo | Norway |
| Research Site | Rud | Norway |
| Research Site | Tynset | Norway |
| Research Site | Bytom | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Košice | Slovakia |
| Research Site | Nitra | Slovakia |
| Research Site | Nové Zámky | Slovakia |
| Research Site | Rimavská Sobota | Slovakia |
| Research Site | Gothenburg | Sweden |
| QTcF>550 ms |
|
| BG002 | Placebo | Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2 |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Adverse Events (AE) | Number of patients who had at least one AE according to the definition in the study protocol | Posted | Number | Participants | During treatment days 2-10 |
|
|
|
| Secondary | Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state | Population PK model parameter estimates derived from plasma concentrations of AZD1305 | Posted | Mean | Full Range | μmol/L | During treatment days 1-10 |
|
|
|
| Secondary | Compliance With Trans Telephonic Monitoring (TTM) | Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis | Posted | Mean | Full Range | Percentage of recordings analysed | During treatment days 1-10 |
|
|
|
| 0 |
| 10 |
| EG001 | AZD1305 Group B | AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 | 3 | 12 |
| EG002 | Placebo | Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2 | 0 | 9 |
| Polymorphic Ventricular Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Palpitation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Application Site Reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Qt Interval Prolonged | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |