UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028788
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

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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 or person

Institute

Daiichi Sankyo Co., Ltd.
Medical Science Department

Institute

Department

Personal name



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

Value
https://center6.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