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
odaclinic@ishinkai-mc.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Senuki |
Organization
Sogo Rinsho Médéfi 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
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
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
