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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002192
Receipt No. 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 2011/07/13

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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 Uncontrolled
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 with calcium channel blocker (Amlodipine)
Interventions/Control_2 antihypertensive therapy with angiotensin converting enzyme blocker (Enalapril)
Interventions/Control_3 antihypertensive therapy 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
Email

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
Email kkajita@gifu-u.ac.jp

Sponsor
Institute Gifu University School of Medicine, General Internal Medicine
Institute
Department

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
Email

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
2011 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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