UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015323 |
|---|---|
| Receipt number | R000017807 |
| Scientific Title | The changes of renin, angiotensin and aldosterone with long term administration of olmesartan:COMPATIBLE extension study |
| Date of disclosure of the study information | 2014/10/03 |
| Last modified on | 2018/08/28 15:23:19 |
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Basic information
Public title
The changes of renin, angiotensin and aldosterone with long term administration of olmesartan:COMPATIBLE extension study
Acronym
COMPATIBLE extension RAS study
Scientific Title
The changes of renin, angiotensin and aldosterone with long term administration of olmesartan:COMPATIBLE extension study
Scientific Title:Acronym
COMPATIBLE extension RAS study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the presence of aldosterone breakthrough or not after long term treatment with olmesartan. We found decreased aldosterone concentration after 3 months and 6 months treatment with olmesartan in COMPATIBLE study, but no available data presents for aldosterone concentration after long term treatment with ARBs over years. The change of aldosterone with long term treatment of ARB may add novel point of view in hypertension treatment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aldosterone concentration
Key secondary outcomes
Renin
Angiotensin I
Angiotensin II
Urinary albumin-to-creatinine ratio
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
Administration of Olmesartan
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who were participants in the prior COMPATIBLE Study, and still takes Olmesartan at the same attended clinic.
Key exclusion criteria
The patient who do not take Olmesartan.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Mori |
Organization
Kanagawa Association of Medical and Dental Practitioners
Division name
Department of Clinical Research
Zip code
Address
TS plaza bldg 2 F, 2-23-2, tsuruya-Cho, Kanagawa-Ku, Yokohama, Japan
TEL
045-313-2111
hmori@gem.hi-ho.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisao Mori |
Organization
Kanagawa Association of Medical and Dental Practitioners
Division name
Department of Clinical Research
Zip code
Address
TS plaza bldg 2 F, 2-23-2, tsuruya-Cho, Kanagawa-Ku, Yokohama, Japan
TEL
045-313-2111
Homepage URL
hmori@gem.hi-ho.ne.jp
Sponsor or person
Institute
Kanagawa Association of Medical and Dental Practitioners
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2014 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 02 | Day |
Last modified on
| 2018 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017807
