UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002192 |
|---|---|
| Receipt number | R000002683 |
| Scientific Title | Effects of antihypertensive therapy on platelet function and insulin sensitivity in patients with glucose intolerance |
| Date of disclosure of the study information | 2009/07/13 |
| Last modified on | 2021/01/25 17:19:13 |
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Basic information
Public title
Effects of antihypertensive therapy on platelet function and insulin sensitivity in patients with glucose intolerance
Acronym
Effects of antihypertensive therapy on platelet function and insulin sensitivity
Scientific Title
Effects of antihypertensive therapy on platelet function and insulin sensitivity in patients with glucose intolerance
Scientific Title:Acronym
Effects of antihypertensive therapy on platelet function and insulin sensitivity
Region
| Japan |
Condition
Condition
patients with glucose intolerance and hypertension
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the effects on platelet function and insulin sensitivity among antihypertensive drugs.
Basic objectives2
Others
Basic objectives -Others
Comparison of the effects on platelet function and insulin sensitivity among the therapy with calcium channel blocker, angiotensin converting enzyme inhibitor and angiotensin receptor blocker
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
platelet aggregation
Key secondary outcomes
plasma glucose level, plasma IRI level
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
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
antihypertensive therapy for 60d with calcium channel blocker(Amlodipine)
Interventions/Control_2
antihypertensive therapy for 60d with angiotensin converting enzyme blocker (Enalapril)
Interventions/Control_3
antihypertensive therapy for 60d with angiotensin receptor blocker (Losartan)
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
non-treated patients having fasting plasma glucose level more than 100 mg/dl and systolic blood pressure more than 130 mmHg and diastolic blood pressure more than 80 mmHg
Key exclusion criteria
1) patients having pregnancy, severe liver, kidney or heart disease
2) patients who have already treated with statin, biguanide or thiazolidine
3) patients who have a history of drug allergy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kajita |
Organization
Gifu University School of Medicine
Division name
General Internal Medicine
Zip code
Address
Yanagido 1-1, Gifu, 501-1194
TEL
058-230-6000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Kajita |
Organization
Gifu University School of Medicine
Division name
General Internal Medicine
Zip code
Address
Yanagido 1-1, Gifu, 501-1194
TEL
058-230-6000
Homepage URL
kkajita@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University School of Medicine, General Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Banyu Pharmaceutical Co
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 13 | 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
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 13 | Day |
Last modified on
| 2021 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002683
| 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 |
