UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013543 |
|---|---|
| Receipt number | R000015241 |
| Scientific Title | The effect of olmesartan on hypertensive cardiac remodeling |
| Date of disclosure of the study information | 2014/03/28 |
| Last modified on | 2016/01/07 11:42:58 |
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Basic information
Public title
The effect of olmesartan on hypertensive cardiac remodeling
Acronym
The effect of olmesartan on hypertensive cardiac remodeling
Scientific Title
The effect of olmesartan on hypertensive cardiac remodeling
Scientific Title:Acronym
The effect of olmesartan on hypertensive cardiac remodeling
Region
| Japan |
Condition
Condition
Hypertension accompanied with cardiovascular disease
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of olmesartan on hypertensive cardiac remodeling by inhibiting hyper activation of rennin-angiotensin system
Basic objectives2
Others
Basic objectives -Others
To compare the changes of cardiac weight and T1 time of Magnetic resonance imaging in the groups with or without olmesartan
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac weight and T1 time of Magnetic resonance imaging
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
olmesartan/intervention
Interventions/Control_2
amlodipine/control
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The cardiac patients who need medical therapy for hypertension.
Key exclusion criteria
The patients whose (a) age <20 or >79, (b) prohibited to MRI, (c) expected high probability of the side-effect of ormethaltan, (d) ejection fraction <40%, (d) patients regarded as inappropriate for the study by doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Adachi |
Organization
National Defense Medical College
Division name
Department of Cardiology
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama, Japan
TEL
0429-95-1511
nmasaki@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Masaki |
Organization
National Defense Medical College
Division name
Department of Cardiology
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama, Japan
TEL
0429-95-1511
Homepage URL
nmasaki@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Fund of National Defense Medical College
Organization
Division
Category of Funding Organization
Other
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
防衛医大病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 28 | 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
This trial was terminated for the reason that enough number of patients could not be recruited.
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
| 2014 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 28 | Day |
Last modified on
| 2016 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015241
| 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 |
