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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000700
Receipt No. R000000838
Scientific Title Target organ damage related gene evaluation using olmesartan in hypertensive patients with diabetes mellitus
Date of disclosure of the study information 2007/05/02
Last modified on 2007/05/02

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Basic information
Public title Target organ damage related gene evaluation using olmesartan in hypertensive patients with diabetes mellitus
Acronym TOGETHER
Scientific Title Target organ damage related gene evaluation using olmesartan in hypertensive patients with diabetes mellitus
Scientific Title:Acronym TOGETHER
Region
Japan

Condition
Condition Hypertension with diabetes mellitus
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Geriatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To identify gene polymorphisms related to cardiovascular-renal protection by angiotensin receptor blockade in hypertensive patients with diabetes mellitus
Basic objectives2 Others
Basic objectives -Others Aim of TOGETHER is to identify gene polymorphisms related to cardiovascular-renal protection by angiotensin receptor blockade in hypertensive patients with diabetes mellitus. Obtained information will be useful for realizing Tailored-medicine for management of hyperetion.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Gene polymorphisms related to to cardiovascular-renal protection by ARB in hypertensive patients with diabetes mellitus
Key secondary outcomes Gene polymorphisms related to to blood pressure reduction or glucose metabolism by ARB in hypertensive patients with diabetes mellitus

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 angiotensin receptor blockade (ARB: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
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Hypertension with diabetes mellitus, who has diabetic nephropathy not including severe renal failure patients with above serum creatinine 2.5mg.
Hypertension with diabetes mellitus without renal failure
Key exclusion criteria Severe hypertensive patients, who have BP above 180/110mmHg
Female patients with pregnancy or possibility of pregnancy
Patients just after acute myocardial infarction or stroke within a month
Inappriate patients for this study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Morisaki
Organization National Cardiovascular Center
Division name Research Institute
Zip code
Address 5-7-1, Fjishirodai, Suita, Osaka 565-8565, Japan
TEL 06-6833-5012
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kei Kamide
Organization National Cardiovascular Center
Division name Division of Hypertension and Nephrology
Zip code
Address 5-7-1, Fjishirodai, Suita, Osaka 565-8565, Japan
TEL 06-6833-5012
Homepage URL
Email kamide@hsp.ncvc.go.jp

Sponsor
Institute National Cardiovascular Center
Institute
Department

Funding Source
Organization Health Sciences of the National Institute of Biomedical Innovation of Japan
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2007 Year 05 Month 02 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
Date of protocol fixation
2006 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2007 Year 01 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 05 Month 02 Day
Last modified on
2007 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000838

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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