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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002054
Receipt No. R000002501
Scientific Title Multiple Accumulated Risk Factors Investigation trial associated with the development of Arteriosclelosis
Date of disclosure of the study information 2009/06/10
Last modified on 2010/01/02

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Basic information
Public title Multiple Accumulated Risk Factors Investigation trial associated with the development of Arteriosclelosis
Acronym Multiple Accumulated Risk Factors Investigation trial associated with the development of Arteriosclelosis (MARIA)
Scientific Title Multiple Accumulated Risk Factors Investigation trial associated with the development of Arteriosclelosis
Scientific Title:Acronym Multiple Accumulated Risk Factors Investigation trial associated with the development of Arteriosclelosis (MARIA)
Region
Japan

Condition
Condition Lifestyle-related diseases
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The investigation of multiple risk factors in early stage associated with the development of arteriosclerosis
Basic objectives2 Others
Basic objectives -Others To investigate some multiple risk factors of arteriosclerotic diseases
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Clinic blood pressure,heart rate.
2.urinary albumin excretion.
3.plasma BNP.
4.Plasma Insulin
5.LDL-C,TG,HDL-C,BUN,Cr,*HbA1c*fasting blood glucose
Key secondary outcomes The influence of the following other risk factors on the early onset in acute myocardial infarction, stroke and death; gender, smoking, hypertension, high TC, high TG, low HDL-C, HOMAR index, BNP, Urinary albumin, eGFR.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Antihypertensive agent (ARB, CCB, Diuretics)
Interventions/Control_2 Hyperlipidemic agent
Interventions/Control_3 Oral diabetes agent
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 1.Out patients
2.Blood pressure (BP):systolic BP (SBP) 140mmHg and above or diastolic BP (DBP) 90mmHg and above.
3.LDL Cholesterol above 140(mg/dL)
4.HDL Cholesterol below 40(mg/dL)
5.Fasting blood sugar (FBS) level above 126 (mg/dL)
6. HbA1c above 6.5%
Key exclusion criteria 1.Malignant hypertension
2.Pregnant women,or Women suspected of being pregnant.
3.Severe liver disorder.
4.Patients who are inadequate to enter this study due to the other reasons by physician's judgments.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaaki Sakai
Organization College of Healthcare Management
Division name Department of Healthcare Management
Zip code
Address 960-4, Takayanagi, Setaka-machi, Miyama-shi Fukuoka 835-0018 JAPAN
TEL 0944-67-7007
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takaaki Sakai
Organization College of Healthcare Management
Division name Department of Healthcare Management
Zip code
Address 960-4, Takayanagi, Setaka-machi, Miyama-shi Fukuoka 835-0018 JAPAN
TEL 0944-67-7007
Homepage URL
Email sakai@minf.med.fukuoka-u.ac.jp

Sponsor
Institute College of Healthcare Management
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 06 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 Open public recruiting
Date of protocol fixation
2009 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 05 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
2009 Year 06 Month 08 Day
Last modified on
2010 Year 01 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002501

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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