UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003047 |
|---|---|
| Receipt number | R000003696 |
| Scientific Title | Examination of improvement of endothelial function in diabetic patients with hypertension |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2015/01/16 13:12:49 |
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Basic information
Public title
Examination of improvement of endothelial function in diabetic patients with hypertension
Acronym
FMD change in diabetic subjects
Scientific Title
Examination of improvement of endothelial function in diabetic patients with hypertension
Scientific Title:Acronym
FMD change in diabetic subjects
Region
| Japan |
Condition
Condition
Diabetes mellitus
Hypertension
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the additional effect of ARB(olmesartan) or Ca-blocker(azelnidipine) on ARB (olmesartan) treated diabetic patients on FMD measurement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference of endothelial function measured by FMD (FLOW Mediated Dilation) before and after the addition of ARB or Ca-blocker
Key secondary outcomes
Difference of blood pressure and urine protein examination before and after the addition of ARB or Ca-blocker
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 considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ARB:olmesartan
Interventions/Control_2
Ca-blocker:azelnidipine
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
1) Subjects are under the treatment of diabetes mellitus
2) Systolic blood pressure more than or equal to 130mmHg, or diastolic blood pressure more than or equal to 80mmHg, measured at the hospital
3) Urine albumin / Cr more than or equal to 300 mg/g cr
4) Serum Cr less than or equal to 2.0 mg/dl
Subjects with all above criteria will be included.
Key exclusion criteria
Subjects who have one or more of the below cases will be excluded.
1) Hypertensive emergency, or under non-oral anti-hypertensive medication
2) Nephritic syndrome (urine protein more than 3.5 g/day, or serum albumin is less than or equal to 3.0 g/dL
3) Subjects who take steroid or immunosuppressor, or ARB other than olmesartan, Ca-blocker other than azelnidipin, anti-fungal agents, HIV protease inhibitor, will be excluded. Subjects who take NSAIDs for more than or equal to 2 weeks will be excluded.
4) Previous history of sever adverse events with Ca-blocker, or ARB or ACE.
5) Subjects experienced brain stroke during six months before taking experimental medication will be excluded.
6) Sever congestive heart failure (NYHA class III or more), sever arrhythmia. Subjects experienced myocardial infarction, or PCT intervention during six months before taking experimental medical will be excluded.
7) Type 1 diabetes mellitus. HbA1C (JDS) more than or equal to 9.0%. Diabetic ketoacidosis
8) Liver dysfunction with increased AST or ALT which are more than 5 times than the upper limit of the standard value.
9) Subjects with malignant tumor
10) Pregnant, or expecting to be pregnant
11) Other problems which investigator (physician) felt inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of endocrinology and dibaetes
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saiama-ken
TEL
049-228-3564
matsudam-ind@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Akiyama |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of endocrinology and dibaetes
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saiama-ken
TEL
049-228-3564
Homepage URL
matsudam-ind@umin.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Department of endocrinology and dibaetes
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
Department of endocrinology and dibaetes
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
埼玉医科大学総合医療センター
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 16 | Day |
Last modified on
| 2015 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003696
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