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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013543
Receipt No. 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

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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
Email 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
Email nmasaki@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015241

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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