UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002054 |
|---|---|
| Receipt number | 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 16:25:06 |
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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
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
sakai@minf.med.fukuoka-u.ac.jp
Sponsor or person
Institute
College of Healthcare Management
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002501
