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To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRI 15mg | Experimental | DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks. |
|
| Normal/MiRI low-dose group | Experimental | DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. |
|
| Normal/MiRI high-dose group | Experimental | DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DU-176b 15mg | Drug | oral DU-176b 15mg once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Any Adjudicated Bleeding Events | Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yukihiro Koretsune, Dir | Osaka National Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Women's Medical University Hospital | Tokyo | 162-0054 | Japan |
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 | SRI 15mg | Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks. DU-176b 15mg: oral DU-176b 15mg once daily |
| FG001 | Normal/MiRI Low-dose Group | Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. DU-176b 30mg: oral DU-176b 30mg once daily |
| FG002 | Normal/MiRI High-dose Group | Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. DU-176b 60mg: oral DU-176b 60mg once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SRI 15mg | Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks. DU-176b 15mg: oral DU-176b 15mg once daily |
| BG001 | Normal/MiRI Low-dose Group |
| 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 Any Adjudicated Bleeding Events | Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding) | Posted | Number | 95% Confidence Interval | percentage of subjects with bleeds | 3 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 | SRI 15mg | Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks. DU-176b 15mg: oral DU-176b 15mg once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Infections and infestations | MedDRA/J V15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | MedDRA/J V15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenichi Sakakura, Manager | Daiichi Sankyo.,LTD | 81-90-1885-0271 | sakakura.kenichi.ef@daiichisankyo.co.jp |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
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| DU-176b 30mg | Drug | oral DU-176b 30mg once daily |
|
|
| DU-176b 60mg | Drug | oral DU-176b 60mg once daily |
|
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
DU-176b 30mg: oral DU-176b 30mg once daily
| BG002 | Normal/MiRI High-dose Group | Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. DU-176b 60mg: oral DU-176b 60mg once daily |
| 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 |
|
| OG002 | Normal/MiRI High-dose Group | Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. DU-176b 60mg: oral DU-176b 60mg once daily |
|
|
|
| 5 |
| 50 |
| 33 |
| 50 |
| EG001 | Normal/MiRI Low-dose Group | Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. DU-176b 30mg: oral DU-176b 30mg once daily | 0 | 22 | 14 | 22 |
| EG002 | Normal/MiRI High-dose Group | Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. DU-176b 60mg: oral DU-176b 60mg once daily | 0 | 21 | 10 | 21 |
| cardiac failure | Cardiac disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| cardiac failure congestive | Cardiac disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| ventricular tachycardia | Cardiac disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA/J V15.1 | Systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| gingival bleeding | Gastrointestinal disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| haematuria | Renal and urinary disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA/J V15.1 | Systematic Assessment |
|
| occult blood | Investigations | MedDRA/J V15.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA/J V15.1 | Systematic Assessment |
|
| gout | Metabolism and nutrition disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| Decreased appetit | Metabolism and nutrition disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| chest pain | General disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA/J V15.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA/J V15.1 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA/J V15.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA/J V15.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA/J V15.1 | Systematic Assessment |
|
| gingivitis | Infections and infestations | MedDRA/J V15.1 | Systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA/J V15.1 | Systematic Assessment |
|
| blood bilirubin increased | Investigations | MedDRA/J V15.1 | Systematic Assessment |
|
PI shall not publish the results of the Study at any time without the prior written approval of Sponsor.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |