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Study of DU-176b Aged 80 Years or Older

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Du-176b
placebo
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring anticoagulants, DU-176b, edoxaban, factor Xa, oral, prevention, atrial fibrillation

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy

Exclusion Criteria:

  • Patients with active bleeding
  • Patients who have poorly controlled hypertension
  • Patients who have liver dysfunction accompanied with disorder of blood coagulation

Sites / Locations

  • Social Corporation Keigakukai Minamiosaka Hospital
  • Hakujikai Memorial Hospital
  • Ageo Central General Hospital
  • Medical Corporation Aijinkai Akashi Medical Center
  • Ako City Hospital
  • Amagasaki New Town Hospital
  • Anjo Kosei Hospital
  • Shin-Ai Kai Honda Hospital
  • Toyooka Chuo Hospital
  • Tokyo Medical and Dental University Medical Hospital
  • Nippon Medical School Hospital
  • Fukuokaken Saiseikai Futsukaichi Hospital
  • Aichi Koseiren Chita Kosei Hospital
  • Kashinoki Internal Medicine Clinic
  • Medical Plaza Edogawa
  • Fukui General Clinic
  • National Hospital Organization Kyushu Medical Center
  • Onga Nakama Medical Association Onga Hospital
  • Fukushima Daiichi Hospital
  • Funabashi Municipal Medical Center
  • Gifu Heart Center
  • Minamino Cardiovascular Hospital
  • Tokyo Tenshi Hospital
  • Social welfare corporation Hakodate koseiin Hakodate Goryoukaku Hospital
  • National Hospital Organization Hakodate Hospital
  • National Hospital Organization Hamada Medical Center
  • Hamamatsu Medical Center
  • Okitama Public General Hospital
  • Social Medical Corporation, the Yamatokai Foundation Central Clinic affiliated clinic of Higashiyamato Hospital
  • Hikone Municipal Hospital
  • Kanazawa Medical University Himi Municipal Hospital
  • Hiratsuka kyosai Hospital
  • Hirosaki Stroke and Rehabilitation Center
  • Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
  • National Hospital Organization Mito Medical Center
  • Nippon Medical School Chiba Hokusoh Hospital
  • Tokai University Hospital
  • Kubo Clinic
  • Shimane University Hospital
  • National Hospital Organization Kagoshima Medical Center
  • National Hospital Organization Kanazawa Medical Center
  • Kasugai Municipal Hospital
  • Asano Kanamachi Clinic
  • Saiseikai Kawaguchi General Hospital
  • St. Marianna University School of Medicine Hospital
  • Kitasato University Medical Center
  • Kobe Rosai Hospital
  • Nose Hospital
  • Medical Corporation Sakurakai Takahashi Hospital
  • Nakayama Clinic of Internal Medicine and Cardiology
  • Yamanashi Prefectural Central Hospital
  • Kanno Reism Heart Clinic
  • Showa University Koto Toyosu Hospital
  • Koto Hospital
  • Saiseikai Kumamoto Hospital
  • Kure Kyosai Hospital
  • Tanushimaru Central Hospital
  • Kusatsu General Hospital
  • Japanese Red Cross Kyoto Daini Hospital
  • National Hospital Organization Kyoto Medical Center
  • Southern Tohoku Research Institute for Neuroscience, Southern Tohoku Medical Clinic
  • Hoshi General Hospital
  • Machida Municipal Hospital
  • National Hospital Organization Maizuru Medical Center
  • New Tokyo Heart Clinic
  • Matsue City Hospital
  • National Hospital Organization Matsumoto Medical Center
  • Matsuyama Red Cross Hospital
  • National Hospital Organization Tokyo Medical Center
  • Miyazaki Medical Association Hospital
  • University of Miyazaki Hospital
  • Iwate Prefectural Central Hospital
  • Nagasaki Harbor Medical Center
  • Nagoya Ekisaikai Hospital
  • Japanese Red Cross Nagoya Daini Hospital
  • Ohama Daiichi Hospital
  • Naha City Hospital
  • Takanohara Central Hospital
  • JCHO Nihonmatsu Hospital
  • Meiwa Hospital
  • Ohyama Memorial Hospital
  • Ogawa Cardiovascular Internal Medicine Clinic
  • Ogaki Municipal Hospital
  • Shimada Hospital
  • Ome Municipal General Hospital
  • National Hospital Organization Nagasaki Medical Center
  • Sakurabashi Watanabe Hospital
  • Osaka City Juso Hospital
  • Kitada Clinic
  • Osaka Police Hospital
  • Osaka General Medical Center
  • Sato Hospital
  • National Hospital Organization Osaka Minami Medical Center
  • Otaru Kyokai Hospital
  • Saga-Ken Medical Centre Koseikan
  • Saitama City Hospital
  • Saitama Memorial Hospital
  • Saku Central Hospital Advanced Care Center
  • Kin-ikyo Chuo Hospital
  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
  • National Hospital Organization Hokkaido Medical Center
  • Sapporo Nishimaruyama Hospital
  • Miyanomori Memorial Hospital
  • Hokkaido Cardiovascular Hospital
  • Shukokai Internal Medicine Sato Hospital
  • KKR Tohoku Kosai Hospital
  • National Hospital Organization Sendai Medical Center
  • Tosei General Hospital
  • National Hospital Organization Kanmon Medical Center
  • Dokkyo Medical University Hospital
  • Tokyo Heart Center
  • Showa University Hospital
  • Center Hospital of the National Center for Global Health and Medicine
  • Shirakawa Hospital
  • Iwate Medical University Hospital
  • National Hospital Organization Shizuoka Medical Center
  • Ikeda Kinen Hospital
  • Iwase General Hospital
  • Hyogo Prefectural Awaji Medical Center
  • Nagano Prefectural Shinshu Medical Hospital
  • National Hospital Organization Disaster Medical Center
  • Social Insurance Tagawa Hospital
  • Kagawa Prefectural Central Hospital
  • Kouseiren Takaoka Hospital
  • Medical Corporation Aishinkai Higashi Takarazuka Satoh Hospital
  • Kan-etsu Chu-oh Hospital
  • Takatsuki General Hospital
  • National Hospital Organization Minami Wakayama Medical Center
  • Tenri Hospital
  • Kuwanomi Hongou Clinic
  • Saino Clinic
  • Tokorozawa Heart Center
  • Tokushima University Hospital
  • Tokushima Prefectural Central Hospital
  • Nerima General Hospital
  • Tomakomai City Hospital
  • Public Tomioka General Hospital
  • National Hospital Organization Ehime Medical Center
  • Yamaguchi Clinic
  • Yayoigaoka Kage Hospital
  • National Hospital Organization Toyohashi Medical Center
  • TOYOTA Memorial Hospital
  • Tsukuba Memorial Hospital
  • Okinawa Prefectural Chubu Hospital
  • National Hospital Organization Tochigi Medical Center
  • Uwajima City Hospital
  • Wakayama Rosai Hospital
  • Nagata Hospital
  • Kumamoto General Hospital
  • Yokohama Municipal Citizen's Hospital
  • Yokohama Rosai Hospital
  • Showa University Fujigaoka Hospital
  • JCHO Yokohama Chuo Hospital
  • Yokohama City Minato Red Cross Hospital
  • Yokohama City University Medical Center
  • Saiseikai Yokohamashi Nanbu Hospital
  • Yokohama Minami Kyousai Hospital
  • National Hospital Organization Yokohama Medical Center
  • Yokohama Sakae Kyosai Hospital
  • Oita Prefectural Hospital
  • Kouhoukai Takagi Hospital
  • Omihachiman Community Medical Center
  • Omori Sanno Hospital
  • JCHO Shiga Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DU-176b 15 mg group

Placebo group

Arm Description

DU-176b orally administered at a dose of 15 mg once daily.

Placebo orally administered once daily.

Outcomes

Primary Outcome Measures

Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With Placebo
Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. A systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).
Number of Participants With Stroke and Systemic Embolic Events (SEE), Including Subcomponents of Stroke and Composite Event of Ischemic Stroke and SEE in Participants Who Were Administered DU-176b Compared With Placebo
Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. Subcomponents of stroke (ischemic and hemorrhagic) were also reported. A systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).

Secondary Outcome Measures

Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and Death Due to Cardiovascular in Participants Who Were Administered DU-176b Compared With Placebo
Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. A systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).
Number of Participants With a Composite Endpoint of a Major Adverse Cardiovascular Event (MACE) in Participants Who Were Administered DU-176b Compared With Placebo
Major adverse cardiovascular events (MACE) included a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic events (SEE), and deaths due to cardiovascular (CV) or bleeding. Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. A SEE was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).
Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and All-Cause Mortality in Participants Who Were Administered DU-176b Compared With Placebo
Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. A systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation). All-cause mortality was defined as death due to cardiovascular and mortality due to all other causes.
Number of Participants With Net Clinical Benefit in Participants Who Were Administered DU-176b Compared With Placebo
Net clinical benefit included a composite of stroke, systemic embolic events (SEE), major bleeding, and all-cause mortality. Stroke was defined as an abrupt onset of symptoms representing focal neurological deficit in the domain supplied by a single brain artery that was not due to an identifiable non-vascular cause. The deficit symptoms had to either last >24 hours or result in death within 24 hours of symptom onset. A SEE was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms. Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion.
Number of Participants With All-Cause Mortality in Participants Who Were Administered DU-176b Compared With Placebo
All-cause mortality was defined as death due to cardiovascular and mortality due to all other causes.
Number of Participants With Major Bleeding During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo
Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion.
Number of Participants With Major Bleeding or Clinically Relevant Non-major Bleedings During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo
Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion. Clinically overt bleeding that required treatment was taken to be clinically relevant non-major bleeding, including for example (but was not limited to) the bleeding that led to the diagnostic tests and treatments as specified in the protocol. The clinically overt bleeding requiring treatment did not include outpatient examinations that did not involve any of the medical procedures (diagnostic tests or treatments) as specified in the protocol.
Number of Participants With All Bleeding Events and Minor Bleeding Events During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo
All bleeding events include major and clinically relevant non-major bleeding events. Other overt bleeding events that did not meet the criteria for major bleeding or clinically relevant non-major bleeding were taken to be minor bleeding (for example, epistaxis that did not require treatment). All events other than the above (such as a decrease in hemoglobin without overt bleeding) were classified as "non-bleeding event."
Plasma Concentration of DU-176 in Participants Who Were Administered DU-176b

Full Information

First Posted
June 13, 2016
Last Updated
November 17, 2020
Sponsor
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02801669
Brief Title
Study of DU-176b Aged 80 Years or Older
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of DU-176b in Patients With NVAF Aged 80 Years or Older Who Are Ineligible for Available Oral Anticoagulation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 5, 2016 (Actual)
Primary Completion Date
December 27, 2019 (Actual)
Study Completion Date
December 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with non-valvular NVAF aged 80 years or older who are ineligible for available oral anticoagulation therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
anticoagulants, DU-176b, edoxaban, factor Xa, oral, prevention, atrial fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
984 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DU-176b 15 mg group
Arm Type
Experimental
Arm Description
DU-176b orally administered at a dose of 15 mg once daily.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo orally administered once daily.
Intervention Type
Drug
Intervention Name(s)
Du-176b
Other Intervention Name(s)
edoxaban
Intervention Description
DU-176b orally administered at a dose of 15 mg once daily.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo orally administered once daily.
Primary Outcome Measure Information:
Title
Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With Placebo
Description
Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. A systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).
Time Frame
Randomization up to the time of onset of the initial composite event of stroke or systemic embolic event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Title
Number of Participants With Stroke and Systemic Embolic Events (SEE), Including Subcomponents of Stroke and Composite Event of Ischemic Stroke and SEE in Participants Who Were Administered DU-176b Compared With Placebo
Description
Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. Subcomponents of stroke (ischemic and hemorrhagic) were also reported. A systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).
Time Frame
Randomization up to the time of onset of the initial composite event of stroke or systemic embolic event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Secondary Outcome Measure Information:
Title
Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and Death Due to Cardiovascular in Participants Who Were Administered DU-176b Compared With Placebo
Description
Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. A systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).
Time Frame
Randomization up to the time of onset of the initial composite event of stroke, systemic embolic event, or death due to CV, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Title
Number of Participants With a Composite Endpoint of a Major Adverse Cardiovascular Event (MACE) in Participants Who Were Administered DU-176b Compared With Placebo
Description
Major adverse cardiovascular events (MACE) included a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic events (SEE), and deaths due to cardiovascular (CV) or bleeding. Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. A SEE was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).
Time Frame
Randomization up to the time of onset of the initial MACE event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Title
Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and All-Cause Mortality in Participants Who Were Administered DU-176b Compared With Placebo
Description
Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. A systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation). All-cause mortality was defined as death due to cardiovascular and mortality due to all other causes.
Time Frame
Randomization up to the time of onset of the initial composite event of stroke, SEE, all-cause mortality, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Title
Number of Participants With Net Clinical Benefit in Participants Who Were Administered DU-176b Compared With Placebo
Description
Net clinical benefit included a composite of stroke, systemic embolic events (SEE), major bleeding, and all-cause mortality. Stroke was defined as an abrupt onset of symptoms representing focal neurological deficit in the domain supplied by a single brain artery that was not due to an identifiable non-vascular cause. The deficit symptoms had to either last >24 hours or result in death within 24 hours of symptom onset. A SEE was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms. Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion.
Time Frame
Randomization up to the time of onset of the initial composite event of stroke, SEE, major bleeding, all-cause mortality, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Title
Number of Participants With All-Cause Mortality in Participants Who Were Administered DU-176b Compared With Placebo
Description
All-cause mortality was defined as death due to cardiovascular and mortality due to all other causes.
Time Frame
Randomization up to death (due to any cause), or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Title
Number of Participants With Major Bleeding During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo
Description
Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion.
Time Frame
Baseline up to study discontinuation or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Title
Number of Participants With Major Bleeding or Clinically Relevant Non-major Bleedings During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo
Description
Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion. Clinically overt bleeding that required treatment was taken to be clinically relevant non-major bleeding, including for example (but was not limited to) the bleeding that led to the diagnostic tests and treatments as specified in the protocol. The clinically overt bleeding requiring treatment did not include outpatient examinations that did not involve any of the medical procedures (diagnostic tests or treatments) as specified in the protocol.
Time Frame
Baseline up to study discontinuation or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Title
Number of Participants With All Bleeding Events and Minor Bleeding Events During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo
Description
All bleeding events include major and clinically relevant non-major bleeding events. Other overt bleeding events that did not meet the criteria for major bleeding or clinically relevant non-major bleeding were taken to be minor bleeding (for example, epistaxis that did not require treatment). All events other than the above (such as a decrease in hemoglobin without overt bleeding) were classified as "non-bleeding event."
Time Frame
Baseline up to study discontinuation or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Title
Plasma Concentration of DU-176 in Participants Who Were Administered DU-176b
Time Frame
Week 8: Predose,1-3 hours (h) and 4-8 h postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy Exclusion Criteria: Patients with active bleeding Patients who have poorly controlled hypertension Patients who have liver dysfunction accompanied with disorder of blood coagulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Social Corporation Keigakukai Minamiosaka Hospital
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
559-0012
Country
Japan
Facility Name
Hakujikai Memorial Hospital
City
Adachi-ku
ZIP/Postal Code
123-0864
Country
Japan
Facility Name
Ageo Central General Hospital
City
Ageo-city
ZIP/Postal Code
362-8588
Country
Japan
Facility Name
Medical Corporation Aijinkai Akashi Medical Center
City
Akashi-city
ZIP/Postal Code
674-0063
Country
Japan
Facility Name
Ako City Hospital
City
Ako-city
ZIP/Postal Code
678-0232
Country
Japan
Facility Name
Amagasaki New Town Hospital
City
Amagasaki-city
ZIP/Postal Code
661-0976
Country
Japan
Facility Name
Anjo Kosei Hospital
City
Anjō-city
ZIP/Postal Code
446-8602
Country
Japan
Facility Name
Shin-Ai Kai Honda Hospital
City
Annaka-city
ZIP/Postal Code
379-0124
Country
Japan
Facility Name
Toyooka Chuo Hospital
City
Asahikawa-city
ZIP/Postal Code
078-8237
Country
Japan
Facility Name
Tokyo Medical and Dental University Medical Hospital
City
Bunkyō-Ku
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Bunkyō-Ku
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Fukuokaken Saiseikai Futsukaichi Hospital
City
Chikushino-city
ZIP/Postal Code
818-8516
Country
Japan
Facility Name
Aichi Koseiren Chita Kosei Hospital
City
Chita
ZIP/Postal Code
470-2404
Country
Japan
Facility Name
Kashinoki Internal Medicine Clinic
City
Date-city
ZIP/Postal Code
960-0418
Country
Japan
Facility Name
Medical Plaza Edogawa
City
Edagawa
ZIP/Postal Code
133-0052
Country
Japan
Facility Name
Fukui General Clinic
City
Fukui-city
ZIP/Postal Code
910-0067
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka-city
ZIP/Postal Code
810-0065
Country
Japan
Facility Name
Onga Nakama Medical Association Onga Hospital
City
Fukuoka
ZIP/Postal Code
811-4342
Country
Japan
Facility Name
Fukushima Daiichi Hospital
City
Fukushima-city
ZIP/Postal Code
960-8251
Country
Japan
Facility Name
Funabashi Municipal Medical Center
City
Funabashi-city
ZIP/Postal Code
273-8588
Country
Japan
Facility Name
Gifu Heart Center
City
Gifu-city
ZIP/Postal Code
500-8384
Country
Japan
Facility Name
Minamino Cardiovascular Hospital
City
Hachiōji-city
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
Tokyo Tenshi Hospital
City
Hachiōji-city
ZIP/Postal Code
193-0811
Country
Japan
Facility Name
Social welfare corporation Hakodate koseiin Hakodate Goryoukaku Hospital
City
Hakodate-city
ZIP/Postal Code
040-8585
Country
Japan
Facility Name
National Hospital Organization Hakodate Hospital
City
Hakodate-city
ZIP/Postal Code
041-8512
Country
Japan
Facility Name
National Hospital Organization Hamada Medical Center
City
Hamada-city
ZIP/Postal Code
697-8511
Country
Japan
Facility Name
Hamamatsu Medical Center
City
Hamamatsu-city
ZIP/Postal Code
432-8580
Country
Japan
Facility Name
Okitama Public General Hospital
City
Higashinakama
ZIP/Postal Code
992-0601
Country
Japan
Facility Name
Social Medical Corporation, the Yamatokai Foundation Central Clinic affiliated clinic of Higashiyamato Hospital
City
Higashiyamato
ZIP/Postal Code
207-0014
Country
Japan
Facility Name
Hikone Municipal Hospital
City
Hikone
ZIP/Postal Code
522-8539
Country
Japan
Facility Name
Kanazawa Medical University Himi Municipal Hospital
City
Himi
ZIP/Postal Code
935-8531
Country
Japan
Facility Name
Hiratsuka kyosai Hospital
City
Hiratsuka-city
ZIP/Postal Code
254-8502
Country
Japan
Facility Name
Hirosaki Stroke and Rehabilitation Center
City
Hirosaki-city
ZIP/Postal Code
036-8104
Country
Japan
Facility Name
Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
City
Hiroshima-city
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
National Hospital Organization Mito Medical Center
City
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Nippon Medical School Chiba Hokusoh Hospital
City
Inzai-city
ZIP/Postal Code
270-1694
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara-city
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kubo Clinic
City
Isesaki
ZIP/Postal Code
372-0841
Country
Japan
Facility Name
Shimane University Hospital
City
Izumo-city
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
National Hospital Organization Kagoshima Medical Center
City
Kagoshima-city
ZIP/Postal Code
892-0853
Country
Japan
Facility Name
National Hospital Organization Kanazawa Medical Center
City
Kanazawa-city
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Kasugai Municipal Hospital
City
Kasugai-city
ZIP/Postal Code
486-8510
Country
Japan
Facility Name
Asano Kanamachi Clinic
City
Katsushikachō
ZIP/Postal Code
125-0041
Country
Japan
Facility Name
Saiseikai Kawaguchi General Hospital
City
Kawaguchi-city
ZIP/Postal Code
332-8558
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital
City
Kawasaki-city
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kitasato University Medical Center
City
Kitamoto-city
ZIP/Postal Code
364-8501
Country
Japan
Facility Name
Kobe Rosai Hospital
City
Kobe city
ZIP/Postal Code
651-0053
Country
Japan
Facility Name
Nose Hospital
City
Kobe-city
ZIP/Postal Code
653-0042
Country
Japan
Facility Name
Medical Corporation Sakurakai Takahashi Hospital
City
Kobe-city
ZIP/Postal Code
654-0026
Country
Japan
Facility Name
Nakayama Clinic of Internal Medicine and Cardiology
City
Kochi-city
ZIP/Postal Code
781-5106
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu-city
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Kanno Reism Heart Clinic
City
Kosugi-shiraishi
ZIP/Postal Code
989-0218
Country
Japan
Facility Name
Showa University Koto Toyosu Hospital
City
Koto-Ku
ZIP/Postal Code
135-8577
Country
Japan
Facility Name
Koto Hospital
City
Koto-Ku
ZIP/Postal Code
136-0072
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto-city
ZIP/Postal Code
861-4193
Country
Japan
Facility Name
Kure Kyosai Hospital
City
Kure-city
ZIP/Postal Code
737-8505
Country
Japan
Facility Name
Tanushimaru Central Hospital
City
Kurume-city
ZIP/Postal Code
839-1213
Country
Japan
Facility Name
Kusatsu General Hospital
City
Kusatsu-city
ZIP/Postal Code
525-8585
Country
Japan
Facility Name
Japanese Red Cross Kyoto Daini Hospital
City
Kyoto-city
ZIP/Postal Code
602-8026
Country
Japan
Facility Name
National Hospital Organization Kyoto Medical Center
City
Kyoto-city
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Southern Tohoku Research Institute for Neuroscience, Southern Tohoku Medical Clinic
City
Kōriyama-city
ZIP/Postal Code
963-8052
Country
Japan
Facility Name
Hoshi General Hospital
City
Kōriyama-city
ZIP/Postal Code
963-8501
Country
Japan
Facility Name
Machida Municipal Hospital
City
Machida-city
ZIP/Postal Code
194-0023
Country
Japan
Facility Name
National Hospital Organization Maizuru Medical Center
City
Maizuru-city
ZIP/Postal Code
625-8502
Country
Japan
Facility Name
New Tokyo Heart Clinic
City
Matsudo-city
ZIP/Postal Code
271-0077
Country
Japan
Facility Name
Matsue City Hospital
City
Matsue-city
ZIP/Postal Code
690-8509
Country
Japan
Facility Name
National Hospital Organization Matsumoto Medical Center
City
Matsumoto-city
ZIP/Postal Code
399-8701
Country
Japan
Facility Name
Matsuyama Red Cross Hospital
City
Matsuyama-city
ZIP/Postal Code
790-8524
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center
City
Meguro-ku
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Miyazaki Medical Association Hospital
City
Miyazaki-city
ZIP/Postal Code
880-0834
Country
Japan
Facility Name
University of Miyazaki Hospital
City
Miyazaki-city
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Iwate Prefectural Central Hospital
City
Morioka-city
ZIP/Postal Code
020-0066
Country
Japan
Facility Name
Nagasaki Harbor Medical Center
City
Nagasaki-city
ZIP/Postal Code
850-8555
Country
Japan
Facility Name
Nagoya Ekisaikai Hospital
City
Nagoya-city
ZIP/Postal Code
454-8502
Country
Japan
Facility Name
Japanese Red Cross Nagoya Daini Hospital
City
Nagoya-city
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Ohama Daiichi Hospital
City
Naha-city
ZIP/Postal Code
900-0005
Country
Japan
Facility Name
Naha City Hospital
City
Naha-city
ZIP/Postal Code
902-8511
Country
Japan
Facility Name
Takanohara Central Hospital
City
Nara-city
ZIP/Postal Code
631-0805
Country
Japan
Facility Name
JCHO Nihonmatsu Hospital
City
Nihonmatsu
ZIP/Postal Code
964-0871
Country
Japan
Facility Name
Meiwa Hospital
City
Nishinomiya-city
ZIP/Postal Code
663-8186
Country
Japan
Facility Name
Ohyama Memorial Hospital
City
Nishiwaki-city
ZIP/Postal Code
679-0321
Country
Japan
Facility Name
Ogawa Cardiovascular Internal Medicine Clinic
City
Obihiro-city
ZIP/Postal Code
080-0871
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki-city
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Shimada Hospital
City
Ogōri-shimogō
ZIP/Postal Code
838-0141
Country
Japan
Facility Name
Ome Municipal General Hospital
City
Ome-city
ZIP/Postal Code
198-0042
Country
Japan
Facility Name
National Hospital Organization Nagasaki Medical Center
City
Omura-city
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
Sakurabashi Watanabe Hospital
City
Osaka-city
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Osaka City Juso Hospital
City
Osaka-city
ZIP/Postal Code
532-0034
Country
Japan
Facility Name
Kitada Clinic
City
Osaka-city
ZIP/Postal Code
538-0044
Country
Japan
Facility Name
Osaka Police Hospital
City
Osaka-city
ZIP/Postal Code
543-0035
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka-city
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Sato Hospital
City
Osaka-city
ZIP/Postal Code
989-6143
Country
Japan
Facility Name
National Hospital Organization Osaka Minami Medical Center
City
Osaka
ZIP/Postal Code
586-0008
Country
Japan
Facility Name
Otaru Kyokai Hospital
City
Otaru-city
ZIP/Postal Code
047-8510
Country
Japan
Facility Name
Saga-Ken Medical Centre Koseikan
City
Saga-city
ZIP/Postal Code
840-8571
Country
Japan
Facility Name
Saitama City Hospital
City
Saitama-city
ZIP/Postal Code
336-8522
Country
Japan
Facility Name
Saitama Memorial Hospital
City
Saitama-city
ZIP/Postal Code
337-0012
Country
Japan
Facility Name
Saku Central Hospital Advanced Care Center
City
Saku-city
ZIP/Postal Code
385-0051
Country
Japan
Facility Name
Kin-ikyo Chuo Hospital
City
Sapporo-city
ZIP/Postal Code
007-8505
Country
Japan
Facility Name
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
City
Sapporo-city
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
National Hospital Organization Hokkaido Medical Center
City
Sapporo-city
ZIP/Postal Code
063-0005
Country
Japan
Facility Name
Sapporo Nishimaruyama Hospital
City
Sapporo-city
ZIP/Postal Code
064-8557
Country
Japan
Facility Name
Miyanomori Memorial Hospital
City
Sapporo-city
ZIP/Postal Code
064-8570
Country
Japan
Facility Name
Hokkaido Cardiovascular Hospital
City
Sapporo-city
ZIP/Postal Code
064-8622
Country
Japan
Facility Name
Shukokai Internal Medicine Sato Hospital
City
Sendai-city
ZIP/Postal Code
980-0011
Country
Japan
Facility Name
KKR Tohoku Kosai Hospital
City
Sendai-city
ZIP/Postal Code
980-0803
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai-city
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Tosei General Hospital
City
Seto-city
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
National Hospital Organization Kanmon Medical Center
City
Shimonoseki-city
ZIP/Postal Code
752-8510
Country
Japan
Facility Name
Dokkyo Medical University Hospital
City
Shimosuga
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Tokyo Heart Center
City
Shinagawa-Ku
ZIP/Postal Code
141-0001
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa-Ku
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Shinjuku-Ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Shirakawa Hospital
City
Shirakawa-city
ZIP/Postal Code
961-0092
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Shiwa-gun
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
National Hospital Organization Shizuoka Medical Center
City
Shizuoka
ZIP/Postal Code
411-8611
Country
Japan
Facility Name
Ikeda Kinen Hospital
City
Sukagawa-city
ZIP/Postal Code
962-0001
Country
Japan
Facility Name
Iwase General Hospital
City
Sukagawa-city
ZIP/Postal Code
962-8503
Country
Japan
Facility Name
Hyogo Prefectural Awaji Medical Center
City
Sumoto-city
ZIP/Postal Code
656-0021
Country
Japan
Facility Name
Nagano Prefectural Shinshu Medical Hospital
City
Suzaka-city
ZIP/Postal Code
382-0000
Country
Japan
Facility Name
National Hospital Organization Disaster Medical Center
City
Tachikawa-city
ZIP/Postal Code
190-0014
Country
Japan
Facility Name
Social Insurance Tagawa Hospital
City
Tagawa
ZIP/Postal Code
826-8585
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu-city
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Kouseiren Takaoka Hospital
City
Takaoka-city
ZIP/Postal Code
933-8555
Country
Japan
Facility Name
Medical Corporation Aishinkai Higashi Takarazuka Satoh Hospital
City
Takarazuka-city
ZIP/Postal Code
665-0873
Country
Japan
Facility Name
Kan-etsu Chu-oh Hospital
City
Takasaki-city
ZIP/Postal Code
370-3513
Country
Japan
Facility Name
Takatsuki General Hospital
City
Takatsuki-city
ZIP/Postal Code
569-1192
Country
Japan
Facility Name
National Hospital Organization Minami Wakayama Medical Center
City
Tanabe-city
ZIP/Postal Code
646-8558
Country
Japan
Facility Name
Tenri Hospital
City
Tenri-city
ZIP/Postal Code
632-8552
Country
Japan
Facility Name
Kuwanomi Hongou Clinic
City
Tokorozawa-city
ZIP/Postal Code
359-0022
Country
Japan
Facility Name
Saino Clinic
City
Tokorozawa-city
ZIP/Postal Code
359-1141
Country
Japan
Facility Name
Tokorozawa Heart Center
City
Tokorozawa-city
ZIP/Postal Code
359-1142
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima-city
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Tokushima Prefectural Central Hospital
City
Tokushima-city
ZIP/Postal Code
770-8539
Country
Japan
Facility Name
Nerima General Hospital
City
Tokyo
ZIP/Postal Code
176-8530
Country
Japan
Facility Name
Tomakomai City Hospital
City
Tomakomai-city
ZIP/Postal Code
053-8567
Country
Japan
Facility Name
Public Tomioka General Hospital
City
Tomioka-city
ZIP/Postal Code
370-2393
Country
Japan
Facility Name
National Hospital Organization Ehime Medical Center
City
Toon-city
ZIP/Postal Code
791-0281
Country
Japan
Facility Name
Yamaguchi Clinic
City
Toshima-ku
ZIP/Postal Code
170-0001
Country
Japan
Facility Name
Yayoigaoka Kage Hospital
City
Tosu
ZIP/Postal Code
841-0005
Country
Japan
Facility Name
National Hospital Organization Toyohashi Medical Center
City
Toyohashi-city
ZIP/Postal Code
440-8510
Country
Japan
Facility Name
TOYOTA Memorial Hospital
City
Toyota-city
ZIP/Postal Code
471-0821
Country
Japan
Facility Name
Tsukuba Memorial Hospital
City
Tsukuba-city
ZIP/Postal Code
300-2622
Country
Japan
Facility Name
Okinawa Prefectural Chubu Hospital
City
Uruma-city
ZIP/Postal Code
904-2293
Country
Japan
Facility Name
National Hospital Organization Tochigi Medical Center
City
Utsunomiya-city
ZIP/Postal Code
320-8580
Country
Japan
Facility Name
Uwajima City Hospital
City
Uwajima
ZIP/Postal Code
798-8510
Country
Japan
Facility Name
Wakayama Rosai Hospital
City
Wakayama-city
ZIP/Postal Code
640-8505
Country
Japan
Facility Name
Nagata Hospital
City
Yanagawa-city
ZIP/Postal Code
832-0059
Country
Japan
Facility Name
Kumamoto General Hospital
City
Yatsushiro-city
ZIP/Postal Code
866-8660
Country
Japan
Facility Name
Yokohama Municipal Citizen's Hospital
City
Yokohama-city
ZIP/Postal Code
221-0855
Country
Japan
Facility Name
Yokohama Rosai Hospital
City
Yokohama-city
ZIP/Postal Code
222-0036
Country
Japan
Facility Name
Showa University Fujigaoka Hospital
City
Yokohama-city
ZIP/Postal Code
227-8501
Country
Japan
Facility Name
JCHO Yokohama Chuo Hospital
City
Yokohama-city
ZIP/Postal Code
231-8553
Country
Japan
Facility Name
Yokohama City Minato Red Cross Hospital
City
Yokohama-city
ZIP/Postal Code
231-8682
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Yokohama-city
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Saiseikai Yokohamashi Nanbu Hospital
City
Yokohama-city
ZIP/Postal Code
234-8503
Country
Japan
Facility Name
Yokohama Minami Kyousai Hospital
City
Yokohama-city
ZIP/Postal Code
236-0037
Country
Japan
Facility Name
National Hospital Organization Yokohama Medical Center
City
Yokohama-city
ZIP/Postal Code
245-8575
Country
Japan
Facility Name
Yokohama Sakae Kyosai Hospital
City
Yokohama-city
ZIP/Postal Code
247-8581
Country
Japan
Facility Name
Oita Prefectural Hospital
City
Ōita-city
ZIP/Postal Code
870-8511
Country
Japan
Facility Name
Kouhoukai Takagi Hospital
City
Ōkawa
ZIP/Postal Code
831-0016
Country
Japan
Facility Name
Omihachiman Community Medical Center
City
Ōmihachiman-city
ZIP/Postal Code
523-0082
Country
Japan
Facility Name
Omori Sanno Hospital
City
Ōta-ku
ZIP/Postal Code
143-0023
Country
Japan
Facility Name
JCHO Shiga Hospital
City
Ōtsu-city
ZIP/Postal Code
520-0846
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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/
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
36056729
Citation
Mikami T, Hirabayashi K, Okawa K, Betsuyaku T, Watanabe S, Imamura Y, Tanizawa K, Hayashi T, Akao M, Yamashita T, Okumura K. Laboratory Test Predictors for Major Bleeding in Elderly (>/=80 Years) Patients With Nonvalvular Atrial Fibrillation Treated With Edoxaban 15 mg: Sub-Analysis of the ELDERCARE-AF Trial. J Am Heart Assoc. 2022 Sep 6;11(17):e024970. doi: 10.1161/JAHA.122.024970. Epub 2022 Sep 3.
Results Reference
derived
PubMed Identifier
35416910
Citation
Kuroda M, Tamiya E, Nose T, Ogimoto A, Taura J, Imamura Y, Fukuzawa M, Hayashi T, Akao M, Yamashita T, Lip GYH, Okumura K. Effect of 15-mg Edoxaban on Clinical Outcomes in 3 Age Strata in Older Patients With Atrial Fibrillation: A Prespecified Subanalysis of the ELDERCARE-AF Randomized Clinical Trial. JAMA Cardiol. 2022 Jun 1;7(6):583-590. doi: 10.1001/jamacardio.2022.0480.
Results Reference
derived
PubMed Identifier
35226559
Citation
Yoshida T, Nakamura A, Funada J, Amino M, Shimizu W, Fukuzawa M, Watanabe S, Hayashi T, Yamashita T, Okumura K, Akao M. Efficacy and Safety of Edoxaban 15 mg According to Renal Function in Very Elderly Patients With Atrial Fibrillation: A Subanalysis of the ELDERCARE-AF Trial. Circulation. 2022 Mar;145(9):718-720. doi: 10.1161/CIRCULATIONAHA.121.057190. Epub 2022 Feb 28. No abstract available.
Results Reference
derived
PubMed Identifier
32865374
Citation
Okumura K, Akao M, Yoshida T, Kawata M, Okazaki O, Akashi S, Eshima K, Tanizawa K, Fukuzawa M, Hayashi T, Akishita M, Lip GYH, Yamashita T; ELDERCARE-AF Committees and Investigators. Low-Dose Edoxaban in Very Elderly Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 29;383(18):1735-1745. doi: 10.1056/NEJMoa2012883. Epub 2020 Aug 30.
Results Reference
derived

Learn more about this trial

Study of DU-176b Aged 80 Years or Older

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