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The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0837 | Drug | ER formulation | ||
| Aspirin | Drug | Oral form |
| Measure | Description | Time Frame |
|---|---|---|
| Premature Discontinuation of Study or Study Drug Due to Any Reason | The premature discontinuation of study or study drug due to any reason | 28 week (randomisation visit to last follow up visit in study) according to protocols |
| Premature Discontinuation of Study Drug Due to Any Reason | The premature discontinuation of study drug due to any reason | 24 weeks (randomisation visit to last treatment visit) |
| Premature Discontinuation of Study Due to Any Reason | |The premature discontinuation of study due to any reason | 28 weeks (randomisation visit to last follow up visit) |
| Compliance With Study Drug | [(number of doses dispensed-number of doses returned)/number of days between visits]*100 | 24 weeks (randomisation visit to last treatment visit) according to protocol |
| Compliance With Study Visits/Assessments | (number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)*100 | 28 weeks (randomisation visit to last follow up visit) according to protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Events | Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once | 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Y Lip, MD | Birmingham City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aalborg | Denmark | ||||
| Research Site |
For participants treated with Vitamin K Antagonists (VKA) at the time of enrollment, VKA treatment was to be adjusted (and stopped before randomisation) to ensure that INR was below 2.0 at randomisation. If this was not achieved the participant was discontinued from the study.
The study population included male and female participants >18 years of age with chronic non-valvular Atrial Fibrillation. The participants were recruited during the time period from 22 October 2007 to 21 October 2008 at medical clinics in Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD0837 150 mg | AZD0837 150 mg |
| FG001 | AZD0837 300 mg | AZD0837 300 mg |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Change in Creatinine Level | Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline) | 4 weeks according to protocol (randomisation visit to week 4 visit) |
| Alanine Aminotransferase (ALAT) | Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal. | 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit) |
| Bilirubin | Number of patients while on study drug with Bilirubin>=2 times upper limit of normal. | 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit) |
| Plasma Concentration of AZD0837 (Prodrug) | Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit | 4 weeks after baseline according to protocol |
| Plasma Concentration of AR-H067637XX (Active Metabolite) | Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit | 4 weeks after baseline according to protocol |
| Change in D-Dimer Level | Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline) | 4 weeks according to protocol.(baseline to week 4 visit) |
| Activated Partial Thromboplastin Time (APTT) | Individual change in Activated partial thromboplastin time (APTT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline) | 4 weeks according to protocol.(baseline to week 4 visit) |
| Ecarin Clotting Time (ECT) | Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline) | 4 weeks according to protocol.(baseline to week 4 visit) |
| Arhus N |
| Denmark |
| Research Site | Copenhagen | Denmark |
| Research Site | Esbjerg | Denmark |
| Research Site | Frederikssund | Denmark |
| Research Site | Horsens | Denmark |
| Research Site | Silkeborg | Denmark |
| Research Site | Svendborg | Denmark |
| Research Site | Elverum | Norway |
| Research Site | Gjettum | Norway |
| Research Site | Kongsberg | Norway |
| Research Site | Oslo | Norway |
| Research Site | Stovner | Norway |
| Research Site | Straume | Norway |
| Research Site | Bytom | Poland |
| Research Site | Częstochowa | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lodz | Poland |
| Research Site | Lublin | Poland |
| Research Site | Ostrów Mazowiecka | Poland |
| Research Site | Otwock | Poland |
| Research Site | Płock | Poland |
| Research Site | Ruda Śląska | Poland |
| Research Site | Sopot | Poland |
| Research Site | Torun | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Borås | Sweden |
| Research Site | Gothenburg | Sweden |
| Research Site | Lund | Sweden |
| Research Site | Malmö | Sweden |
| Research Site | Mölndal | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Birmingham | United Kingdom |
| Research Site | Eastbourne | United Kingdom |
| Research Site | Newcastle upon Tyne | United Kingdom |
| Standard Therapy |
Standard Therapy |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD0837 150 mg | AZD0837 150 mg |
| BG001 | AZD0837 300 mg | AZD0837 300 mg |
| BG002 | Standard Therapy | Standard Therapy |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Premature Discontinuation of Study or Study Drug Due to Any Reason | The premature discontinuation of study or study drug due to any reason | Posted | Number | Participants | 28 week (randomisation visit to last follow up visit in study) according to protocols |
|
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| Primary | Premature Discontinuation of Study Drug Due to Any Reason | The premature discontinuation of study drug due to any reason | Posted | Number | Participants | 24 weeks (randomisation visit to last treatment visit) |
|
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| Primary | Premature Discontinuation of Study Due to Any Reason | |The premature discontinuation of study due to any reason | Posted | Number | Participants | 28 weeks (randomisation visit to last follow up visit) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Compliance With Study Drug | [(number of doses dispensed-number of doses returned)/number of days between visits]*100 | Posted | Mean | Standard Deviation | Percentage | 24 weeks (randomisation visit to last treatment visit) according to protocol |
|
| |||||||||||||||||||||||||||||||||
| Primary | Compliance With Study Visits/Assessments | (number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)*100 | Posted | Mean | Standard Deviation | Percentage | 28 weeks (randomisation visit to last follow up visit) according to protocol |
|
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| Secondary | Bleeding Events | Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once | 41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3 | Posted | Number | Participants | 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Creatinine Level | Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline) | Posted | Mean | Standard Deviation | umol/L | 4 weeks according to protocol (randomisation visit to week 4 visit) |
|
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| Secondary | Alanine Aminotransferase (ALAT) | Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal. | 41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3 | Posted | Number | Participants | 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit) |
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| Secondary | Bilirubin | Number of patients while on study drug with Bilirubin>=2 times upper limit of normal. | 41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3 | Posted | Number | Participants | 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit) |
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| Secondary | Plasma Concentration of AZD0837 (Prodrug) | Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit | Posted | Median | Full Range | nmol/L | 4 weeks after baseline according to protocol |
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| Secondary | Plasma Concentration of AR-H067637XX (Active Metabolite) | Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit | Posted | Median | Full Range | nmol/L | 4 weeks after baseline according to protocol |
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| Secondary | Change in D-Dimer Level | Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline) | Posted | Median | Full Range | ng/ml | 4 weeks according to protocol.(baseline to week 4 visit) |
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| Secondary | Activated Partial Thromboplastin Time (APTT) | Individual change in Activated partial thromboplastin time (APTT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline) | Posted | Median | Full Range | sec | 4 weeks according to protocol.(baseline to week 4 visit) |
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| Secondary | Ecarin Clotting Time (ECT) | Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline) | Posted | Median | Full Range | sec | 4 weeks according to protocol.(baseline to week 4 visit) |
|
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41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
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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 | AZD0837 150 mg | AZD0837 150 mg | 2 | 41 | 3 | 41 | ||
| EG001 | AZD0837 300 mg | AZD0837 300 mg | 3 | 41 | 1 | 41 | ||
| EG002 | Standard Therapy | Standard Therapy | 2 | 46 | 1 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Drug Intolerance | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Podagra | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | +44 1509 645895 | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| C551586 | AZD 0837 |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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