UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of sensory evaluation using edoxaban orally disintegrating tablet (OD tablet)
Title of the study (Brief title)	Sensory evaluation study of edoxaban OD tablet
Region	Japan

Condition
Condition	Nonvalvular atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Others
Basic objectives -Others	Evaluation of sensory
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of sensory
Key secondary outcomes	Evaluation of safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Edoxaban tosilate hydrate OD tablets 30 mg without water.
Interventions/Control_2	Edoxaban tosilate hydrate OD tablets 60 mg without water.
Interventions/Control_3	Edoxaban tosilate hydrate OD tablets 30 mg with water.
Interventions/Control_4	Edoxaban tosilate hydrate OD tablets 60 mg with water.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	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.
Target sample size	100

Research contact person
Name of lead principal investigator	1)Takeshi Yamashita 2)Joji Hagii
Organization	1)The Cardiovascular Institute Hospital 2)Hirosaki Stroke and Rehabilitation Center
Division name	1)Director 2)Director of Internal Medicine
Address	1)3-2-19 Nishiazabu, Minato-Ku, Tokyo 106-0031 2)1-2-1, Ogimachi, Hirosaki City, Aomori 036-8104
TEL	03-3408-2151
Email	yamt-tky@umin.ac.jp

Public contact
Name of contact person	Jun Okada
Organization	EP-CRSU Co., Ltd.
Division name	Clinical Research Project Division Research Promotion Dept.
Address	Acropolis Tokyo Building 3F, 6-29 Shinogawamachi Shinjuku-ku, Tokyo 162-0814
TEL	03-5804-5045
Homepage URL
Email	prj-edo-od@eps.co.jp

Sponsor
Institute	Daiichi Sankyo Co., Ltd. Medical Science Department
Institute
Department

Funding Source
Organization	Daiichi Sankyo Co., Ltd. Medical Science Department
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 26 Day
Anticipated trial start date	2017 Year 08 Month 24 Day
Last follow-up date	2018 Year 01 Month 26 Day
Date of closure to data entry	2018 Year 01 Month 26 Day
Date trial data considered complete	2018 Year 02 Month 08 Day
Date analysis concluded	2018 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 23 Day
Last modified on	2018 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032546