Unique ID issued by UMIN | UMIN000028788 |
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Receipt number | R000032546 |
Scientific Title | Clinical study of sensory evaluation using edoxaban orally disintegrating tablet (OD tablet) |
Date of disclosure of the study information | 2017/08/24 |
Last modified on | 2018/06/22 15:06:56 |
Clinical study of sensory evaluation using edoxaban orally disintegrating tablet (OD tablet)
Sensory evaluation study of edoxaban OD tablet
Clinical study of sensory evaluation using edoxaban orally disintegrating tablet (OD tablet)
Sensory evaluation study of edoxaban OD tablet
Japan |
Nonvalvular atrial fibrillation
Cardiology |
Others
NO
Sensory evaluation of edoxaban tosilate hydrate OD tablets (30 mg, 60 mg) are conducted in patients with nonvalvular atrial fibrillation who are taking edoxaban tosilate hydrate tablets.
Others
Evaluation of sensory
Exploratory
Pragmatic
Not applicable
Evaluation of sensory
Evaluation of safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
No need to know
4
Treatment
Medicine |
Edoxaban tosilate hydrate OD tablets 30 mg without water.
Edoxaban tosilate hydrate OD tablets 60 mg without water.
Edoxaban tosilate hydrate OD tablets 30 mg with water.
Edoxaban tosilate hydrate OD tablets 60 mg with water.
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients who are 20 years of age or older at the time of informed consent.
2) Patients who have been taking 30mg or 60mg of edoxaban tablets for more than 2 weeks before obtaining informed consent.
3) Patients who provided voluntary consent to participate in the study after receiving sufficient explanation.
1)Patients who are taking dual anti-platelet therapy.
2)Patients who have experienced any cardiovascular events (stroke, myocardial infarction, cardiac intervention for cardiac events other than myocardial infarction, or heart failure requiring hospitalization) or any bleeding leading to hospitalization within two weeks before enrollment.
3) Patients who are pregnant or breast-feeding, or who have possibility to be pregnant.
4) Patients who are judged unsuitable for this study by the investigators.
100
1st name | |
Middle name | |
Last name | 1)Takeshi Yamashita 2)Joji Hagii |
1)The Cardiovascular Institute Hospital
2)Hirosaki Stroke and Rehabilitation Center
1)Director 2)Director of Internal Medicine
1)3-2-19 Nishiazabu, Minato-Ku, Tokyo 106-0031 2)1-2-1, Ogimachi, Hirosaki City, Aomori 036-8104
03-3408-2151
yamt-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Jun Okada |
EP-CRSU Co., Ltd.
Clinical Research Project Division Research Promotion Dept.
Acropolis Tokyo Building 3F, 6-29 Shinogawamachi Shinjuku-ku, Tokyo 162-0814
03-5804-5045
prj-edo-od@eps.co.jp
Daiichi Sankyo Co., Ltd.
Medical Science Department
Daiichi Sankyo Co., Ltd.
Medical Science Department
Profit organization
Japan
NO
2017 | Year | 08 | Month | 24 | Day |
Published
Completed
2017 | Year | 07 | Month | 26 | Day |
2017 | Year | 08 | Month | 24 | Day |
2018 | Year | 01 | Month | 26 | Day |
2018 | Year | 01 | Month | 26 | Day |
2018 | Year | 02 | Month | 08 | Day |
2018 | Year | 02 | Month | 28 | Day |
2017 | Year | 08 | Month | 23 | Day |
2018 | Year | 06 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032546
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