UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000700 |
|---|---|
| Receipt number | 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 15:15:28 |
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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
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
kamide@hsp.ncvc.go.jp
Sponsor or person
Institute
National Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000838
