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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019202
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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