UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019202
Receipt number R000022200
Scientific Title Clinical study of sensory evaluation using Olmesartan orally disintegrating tablet (OD tablets) for hypertensive patients.
Date of disclosure of the study information 2015/10/01
Last modified on 2017/10/30 10:25:38

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Basic information

Public title

Clinical study of sensory evaluation using Olmesartan orally disintegrating tablet (OD tablets) for hypertensive patients.

Acronym

Clinical study of sensory evaluation using Olmesartan orally disintegrating tablet (OD tablets) for hypertensive patients.

Scientific Title

Clinical study of sensory evaluation using Olmesartan orally disintegrating tablet (OD tablets) for hypertensive patients.

Scientific Title:Acronym

Clinical study of sensory evaluation using Olmesartan orally disintegrating tablet (OD tablets) for hypertensive patients.

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Sensory evaluation are conducted by taking Olmesartan OD tablets 20mg 1 tablet / day for hypertensive patients using Olmesartan tablets 20mg.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


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

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Hypertensive patients using Olmesartan tablets 20mg take Olmesartan OD tablets 20mg.Intervention period : 1 day

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


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 moment obtaining informed consent.
2) Patients who are already taking Olmesartan tablets 20mg from before more than two weeks of obtaining informed consent.
3) Patients who provided voluntary informed consent to participate in the study after receiving sufficient explanation.

Key exclusion criteria

1) Patients who are taking dementia therapeutics.
2) Patients who are a history of hypersensitivity to Olmesartan tablet.
3) Diabetic patients who are taking aliskiren fumarate(Except for uncontrolled patients of blood pressure by doing other antihypertensive treatment.)
4) Patients who are pregnant or during lactation, or there is becoming the possibility of pregnant.
5) Patients who jugged unsuitable for this study by the investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Harunori Oda

Organization

Medical corporation Ishinkai
Oda clinic

Division name

Medecine Gastroenterological medicine Surgery

Zip code


Address

Daito Building 2F, 1-11-3, Okubo

TEL

03-5273-0770

Email

odaclinic@ishinkai-mc.net


Public contact

Name of contact person

1st name
Middle name
Last name Kotaro Senuki

Organization

Sogo Rinsho M&eacute;d&eacute;fi Co,Ltd.

Division name

Business Promotion Department

Zip code


Address

9F KDX Shinjuku Building 3-2-7 Nishi Shinjuku

TEL

03-6901-6079

Homepage URL


Email

OLM-OD@sogo-medefi.jp


Sponsor or person

Institute

Medical corporation Ishinkai
Oda clinic

Institute

Department

Personal name



Funding Source

Organization

Daiichi Sankyo Company, Limited

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

医療法人社団医進会 小田クリニック


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 01 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

2015 Year 08 Month 05 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 13 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2015 Year 11 Month 12 Day

Date analysis concluded

2015 Year 12 Month 02 Day


Other

Other related information



Management information

Registered date

2015 Year 10 Month 01 Day

Last modified on

2017 Year 10 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022200


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name