UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009847 |
|---|---|
| Receipt number | R000011538 |
| Scientific Title | The difference of the effect of ARB on blood pressure and CARDIac functiOn in patients with essential hypertension |
| Date of disclosure of the study information | 2013/01/23 |
| Last modified on | 2015/07/23 22:46:47 |
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Basic information
Public title
The difference of the effect of ARB on blood pressure and CARDIac functiOn in patients with essential hypertension
Acronym
CARDIO Study
Scientific Title
The difference of the effect of ARB on blood pressure and CARDIac functiOn in patients with essential hypertension
Scientific Title:Acronym
CARDIO Study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare differnce of the effect of ARB on blood pressure and CARDIac functiOn in patients with essential hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure
Cardiac function
Key secondary outcomes
Endocrine parameters
Vascular function
Renal function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
olmesartan20mg
Interventions/Control_2
azilsatan20mg
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Receiving treatment with ARB usual dose(except for olmesartan and azilsartan) for more than six weeks before registration
Key exclusion criteria
1)Hypertensive emergency that requires intravenous administration of antihypertensives
2)Receiving treatment with olmesartan or azilesartan in less than 8 weeks before registration
3)Receiving treatment with Aldosterone antagonists in less than 8 weeks before registration
4)Secondary hypertension
5) Nephritic syndrome
6)Severe renal disease
7)Severe hepatic and biliary tract dysfunction
8) History of cardiovascular events and malignancy within less than 6weeks before registration
9) Pregnancy,the possibility of pregnancy, or the desire to become pregnant.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Takami |
Organization
Clinic Jingumae
Division name
Internal Medicine
Zip code
Address
5-4-41 Naizencho Kashihara Nara
TEL
0744-23-8568
takami66@m5.kcn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Takami |
Organization
Clinic Jingumae
Division name
Internal Medicine
Zip code
Address
5-4-41 Naizencho Kashihara Nara
TEL
0744-23-8568
Homepage URL
takami66@m5.kcn.ne.jp
Sponsor or person
Institute
Clinic Jingumae
Institute
Department
Personal name
Funding Source
Organization
Clinic Jingumae
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kagawa University Faculty of medicine
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
| 2013 | Year | 01 | Month | 23 | 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
Primary end-point
Central blood pressure was improved with both groups, and there is not the difference between groups.
Left ventricular mass, left ventricular dilatation ability was not the change with both groups either, and there is not the difference between groups.
Aldosterone was improved with both groups, there was not the difference between groups.
There was not significant relationship between left ventricular mass, left ventricular dilatation and plasma aldosterone in both groups.
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
| 2012 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 08 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 18 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 10 | Day |
Other
Other related information
Secondary end points
SBP, urinary angiotensinogen and urinary albumin were improved with both groups, and there is not the difference between groups.
Subanalisis
There was significant relationship betweent the changes of urinary albumin and the changes of urinary angiotensinogen.
Management information
Registered date
| 2013 | Year | 01 | Month | 23 | Day |
Last modified on
| 2015 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011538
