UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003576 |
|---|---|
| Receipt number | R000004337 |
| Scientific Title | Management and improvement by ARB with Ca channel blocker in hypertensive patients with diabetes STUDY |
| Date of disclosure of the study information | 2010/05/10 |
| Last modified on | 2011/01/14 16:32:31 |
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Basic information
Public title
Management and improvement by ARB with Ca channel blocker in hypertensive patients with diabetes STUDY
Acronym
MINATO STUDY
Scientific Title
Management and improvement by ARB with Ca channel blocker in hypertensive patients with diabetes STUDY
Scientific Title:Acronym
MINATO STUDY
Region
| Japan |
Condition
Condition
Hypertensive patients with diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of combination effect of ARB and Ca channel blocker in hypertensive patients with diabetes.
Evaluation of effects of various antihypertensives on central blood pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure:Systolic Blood Pressure, Diastolic Blood Pressure.Home Blood Pressure(Conforming to JSH2009)
Central Blood Pressure
Heart rate
Smoking History
Augmentaion index (AIx)
Cardio Ankle Vascular Index(CAVI)
Salt excretion In Spot Urine
Urinary albumin
Urinary creatinine
Urinary sodium
Urinary Potassium
Serum Creatinine
Serum Sodium
Serum Potassium
Plasma Aldosterone Concentration
PAI-1
Plasma Renin Activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
At study entry, administrating ARB and Calcium channel blocker will be changed to Olmesartan (20 mg/day) and Azelnidipine (16 mg/day) and administered for 3 months. The drugs will be then switched to Valsartan(80mg/day) and Amlodipine(5mg/day) and treatment will be continued for another 3 months.
Interventions/Control_2
At study entry, administrating ARB and Calcium channel blocker will be changed to Valsartan(80mg/day) and Amlodipine(5mg/day) and administered for 3 months. The drugs will be then switched to Olmesartan (20 mg/day) and Azelnidipine (16 mg/day) and treatment will be continued for another 3 months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hypertention patients with type 2 diabetes mellitus.
Key exclusion criteria
Contraindication of Olmesartan and Valsartan.
Contraindication of Azelnidipin and Amlodipin
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Utsunomiya |
Organization
The jikei University School of Medicin
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
3-19-18, Nishishinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
3-19-18, Nishishinbashi, Minato-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
The 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
| 2010 | Year | 05 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 07 | Day |
Last modified on
| 2011 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004337
| 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 |
