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This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses. Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary endpoints are incidence of major, clinically relevant non-major and minor bleeding events (all bleeding).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental | DU-176b tablets: high-dose |
|
| 3 | Active Comparator | Warfarin tablets |
|
| 1 | Experimental | DU-176b tablets: low-dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DU-176b tablets | Drug | DU-176b tablets taken once daily for up to 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All Bleeding | Incidence of all bleeding (major, clinically relevant non-major and minor) in two fixed dosage of DU-176b in comparison with warfarin as active control in subjects with non-valvular AF. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Incidence of Major Adverse Cardiovascular Events: Stroke, Systemic Embolic Event, Myocardial Infarction, Cardiovascular Death, and Hospitalization for Any Cardiac Condition | 6 months | |
| Evaluation of Effects on Biomarkers of Thrombus Formation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong | China | |||||
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | DU176b 30mg | 30 mg of DU-176b was administered once daily in the morning in principle for 3 months. |
| FG001 | DU-176b 60 mg | 60 mg of DU-176b was administered once daily in the morning in principle for 3 months. |
| FG002 | Warfarin Potassium | Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DU176b 30mg | 30 mg of DU-176b was administered once daily in the morning in principle for 3 months. |
| BG001 | DU-176b 60 mg | 60 mg of DU-176b was administered once daily in the morning in principle for 3 months. |
| 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 | Incidence of All Bleeding | Incidence of all bleeding (major, clinically relevant non-major and minor) in two fixed dosage of DU-176b in comparison with warfarin as active control in subjects with non-valvular AF. | The Safety Analysis Set was defined as all subjects who received at least one dose of study drug and had at least one post-dose safety assessment. The primary endpoint were analyzed for the subjects who proceeded to the treatment period in the Safety Analysis Set. | Posted | Number | 95% Confidence Interval | percentage of subjects with bleeds | 6 months |
|
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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 | DU176b 30mg | 30 mg of DU-176b was administered once daily in the morning in principle for 3 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac failure congestive | Cardiac disorders | MedDRA v.10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Atsushi Nonogaki, Manager | Daiichi Sankyo.,LTD | 81-80-3029-7553 | nonogaki.atsushi.zz@daiichisankyo.co.jp |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| DU-176b tablets |
| Drug |
DU-176b tablets taken once daily for up to 3 months |
|
| Warfarin tablets | Drug | Warfarin tablets taken once daily for up to 3 months |
|
| 6 months |
| Evaluation of Plasma Concentration of DU-176 | 6 months |
| Evaluation of Effects on Pharmacodynamic Biomarkers | 6 months |
| Evaluation of All Clinical and Laboratory Safety Data. | 6 months |
| Singapore |
| Singapore |
| Seoul | South Korea |
| Taipei | Taiwan |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| discontinued before start of treatment |
|
| BG002 | Warfarin Potassium | Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
60 mg of DU-176b was administered once daily in the morning in principle for 3 months. |
| OG002 | Warfarin Potassium | Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months. |
|
|
|
| Secondary | Evaluation of Incidence of Major Adverse Cardiovascular Events: Stroke, Systemic Embolic Event, Myocardial Infarction, Cardiovascular Death, and Hospitalization for Any Cardiac Condition | Not Posted | 6 months | Participants |
| Secondary | Evaluation of Effects on Biomarkers of Thrombus Formation | Not Posted | 6 months | Participants |
| Secondary | Evaluation of Plasma Concentration of DU-176 | Not Posted | 6 months | Participants |
| Secondary | Evaluation of Effects on Pharmacodynamic Biomarkers | Not Posted | 6 months | Participants |
| Secondary | Evaluation of All Clinical and Laboratory Safety Data. | Not Posted | 6 months | Participants |
| 3 |
| 79 |
| 62 |
| 79 |
| EG001 | DU-176b 60 mg | 60 mg of DU-176b was administered once daily in the morning in principle for 3 months. | 10 | 80 | 65 | 80 |
| EG002 | Warfarin Potassium | Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months. | 5 | 75 | 59 | 75 |
| Coronary artery disease | Cardiac disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Hydrocele | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v.10.1 | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v.10.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v.10.1 | Systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v.10.1 | Systematic Assessment |
|
| Concussion | Nervous system disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Back injury | Musculoskeletal and connective tissue disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Neck injury | Musculoskeletal and connective tissue disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Gingival bleeding | Blood and lymphatic system disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Hypertensive crisis | Cardiac disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v.10.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v.10.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v.10.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v.10.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v.10.1 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA v.10.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| peptic ulcer | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| periodontitis | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| toothache | Gastrointestinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| chest pain | General disorders | MedDRA v.10.1 | Systematic Assessment |
|
| fatigue | General disorders | MedDRA v.10.1 | Systematic Assessment |
|
| influenza | Infections and infestations | MedDRA v.10.1 | Systematic Assessment |
|
| contusion | Injury, poisoning and procedural complications | MedDRA v.10.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA v.10.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA v.10.1 | Systematic Assessment |
|
| Glucose tolerance test abnormal | Investigations | MedDRA v.10.1 | Systematic Assessment |
|
| Hypertriglyceridaemia | Investigations | MedDRA v.10.1 | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | MedDRA v.10.1 | Systematic Assessment |
|
| myositis | Musculoskeletal and connective tissue disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v.10.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v.10.1 | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | MedDRA v.10.1 | Systematic Assessment |
|
| flushing | Vascular disorders | MedDRA v.10.1 | Systematic Assessment |
|
Korea study sites agree that any results of the study are not to be published individually or collectively in whole or part by study site, its employees or agents until after the coordinated multicenter publication or one year after the termination of the study, whichever occurs fist.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |