UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001080 |
|---|---|
| Receipt number | R000001315 |
| Scientific Title | Jikei Nateglinide and Arbs for Vascular Intervention Study |
| Date of disclosure of the study information | 2008/03/15 |
| Last modified on | 2015/07/09 23:35:37 |
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Basic information
Public title
Jikei Nateglinide and Arbs for Vascular Intervention Study
Acronym
J-NAVI
Scientific Title
Jikei Nateglinide and Arbs for Vascular Intervention Study
Scientific Title:Acronym
J-NAVI
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the anti-anteriosclerotic effects as change in carotid plaque volume using 3-Dimensional Ultrasound with type 2 diabetes and hypertension treated with either Telmisartan or Valsartan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in cartoid plaque volume after
24 weeks using 3-Dimensional Ultrasound
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nateglinide 30 to 90mg per times and
Valsartan 80mg
Interventions/Control_2
Nateglinide 30 to 90mg per times and
Telmisartan 40mg
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients with hypertension gave written informed consent to participate in the study,and treated with Nateglinide
and ARB.
Key exclusion criteria
1)Patients with severe heart disease
2)Patients with severe liver dysfunction
3)Patients with poor glycemic controls(glycated hemoglobin >8.0%)
4)Drug allegy to ARB
5)Patients with hemodialysis
6)Pregnant or possibility of pregnant
7)Patients that treated with pioglitazone within 6 months
8)Patients with renal dysfunction(serum creatinine>3.0mg/dl)
9)Other patients judged inappropriate for the study by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Taki |
Organization
Tokyo Jikei university school of medicine
Division name
Diabetes,metabolism and endocrinology
Zip code
Address
3-25-8,nishi-shinbashi,minato-ku,Tokyo,japan
TEL
03-3433-1111
tackey@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Taki |
Organization
Tokyo Jikei university school of medicine
Division name
Diabetes,metabolism and endocrinology
Zip code
Address
3-25-8,nishi-shinbashi,minato-ku,Tokyo,japan
TEL
03-3433-1111
Homepage URL
tackey@jikei.ac.jp
Sponsor or person
Institute
tokyo jikei university school of medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine, Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2008 | Year | 03 | Month | 15 | 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
Completed
Date of protocol fixation
| 2007 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | 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
| 2008 | Year | 03 | Month | 15 | Day |
Last modified on
| 2015 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001315
