UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of sensory evaluation using Olmesartan orally disintegrating tablet (OD tablets) for hypertensive patients.
Title of the study (Brief title)	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	Harunori Oda
Organization	Medical corporation Ishinkai Oda clinic
Division name	Medecine Gastroenterological medicine Surgery
Address	Daito Building 2F, 1-11-3, Okubo
TEL	03-5273-0770
Email	odaclinic@ishinkai-mc.net

Public contact
Name of contact person	Kotaro Senuki
Organization	Sogo Rinsho Médéfi Co,Ltd.
Division name	Business Promotion Department
Address	9F KDX Shinjuku Building 3-2-7 Nishi Shinjuku
TEL	03-6901-6079
Homepage URL
Email	OLM-OD@sogo-medefi.jp

Sponsor
Institute	Medical corporation Ishinkai Oda clinic
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022200