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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028788
Receipt No. 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

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Basic information
Public title Clinical study of sensory evaluation using edoxaban orally disintegrating tablet (OD tablet)
Acronym Sensory evaluation study of edoxaban OD tablet
Scientific Title Clinical study of sensory evaluation using edoxaban orally disintegrating tablet (OD tablet)
Scientific Title:Acronym 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
1st name
Middle name
Last name 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
Zip code
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
1st name
Middle name
Last name Jun Okada
Organization EP-CRSU Co., Ltd.
Division name Clinical Research Project Division Research Promotion Dept.
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 07 Month 26 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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