UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007273 |
|---|---|
| Receipt number | R000008567 |
| Scientific Title | Cardioprotective effect of ARB in old patients with hypertension and coronary artery disease - a multicenter trial -. |
| Date of disclosure of the study information | 2012/02/13 |
| Last modified on | 2016/08/17 21:06:07 |
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Basic information
Public title
Cardioprotective effect of ARB in old patients with hypertension and coronary artery disease - a multicenter trial -.
Acronym
Cardioprotection in the elderly by ARB
Scientific Title
Cardioprotective effect of ARB in old patients with hypertension and coronary artery disease - a multicenter trial -.
Scientific Title:Acronym
Cardioprotection in the elderly by ARB
Region
| Japan |
Condition
Condition
Elderly patients with hypertension and coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical effects of PPARgamma-activated by irbesartan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in calcium score of coronary artery and aortic valve from baseline
Change in echocardiography from baseline
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Irbesartan
Interventions/Control_2
Valsartan or Candesartan
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
History of coronary artery disease
Over 60 years
Hypertension
and with at least one of risks of
Diabetes mellitus
Chronic kidney disease
Obesity
Key exclusion criteria
Previous ARB-induced
Hypersensitivity to ARB
Serious impairment of liver function
Serious renal dysfunction
Hemodialysis treated
Pregnant woman or who has possibility
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Nakatani |
Organization
Osaka University Graduate School of medicine
Division name
Division of Functional Diagnostics, Department of Health Sciences
Zip code
Address
1-7 Yamada-oka, suita Osaka
TEL
06-6879-2561
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Nakatani |
Organization
Osaka University Graduate School of medicine
Division name
Division of Functional Diagnostics, Department of Health Sciences
Zip code
Address
TEL
06-6879-2561
Homepage URL
Sponsor or person
Institute
Association of APPOINT-study
Institute
Department
Personal name
Funding Source
Organization
Associations for establishment of evidence in interventions
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 02 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 13 | Day |
Last modified on
| 2016 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008567
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
