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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002835
Receipt No. R000003461
Scientific Title analysis of EPA/AA in the connective tissue disease patients complicated with hypertension, hyperlipidemia, and DM
Date of disclosure of the study information 2009/12/03
Last modified on 2009/12/03

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Basic information
Public title analysis of EPA/AA in the connective tissue disease patients complicated with hypertension, hyperlipidemia, and DM
Acronym analysis of EPA/AA in the connective tissue disease patients complicated with hypertension, hyperlipidemia, and DM
Scientific Title analysis of EPA/AA in the connective tissue disease patients complicated with hypertension, hyperlipidemia, and DM
Scientific Title:Acronym analysis of EPA/AA in the connective tissue disease patients complicated with hypertension, hyperlipidemia, and DM
Region
Japan

Condition
Condition the connective tissue disease patients complicated with hypertension, hyperlipidemia, and DM
Classification by specialty
Cardiology Endocrinology and Metabolism Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of EPA/AA in the connective tissue disease patients complicated with hypertension, hyperlipidemia, and DM
Basic objectives2 Others
Basic objectives -Others epidemiology
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1)Complicated ratio of hypertension, hyperlipidemia, and DM in the connective tissue disease patients
2)serum EPA/AA in the connective tissue disease patients
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria connective tissue disease outpatients
Key exclusion criteria none
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Hagihara
Organization Osaka University Graduate School of Medicine
Division name Department of Respiratory Medicine, Allergy, and Rheumatic Diseases
Zip code
Address 2-2,Yamadaoka, Suita City, Osaka,Japan
TEL 06-6879-3833
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Medicine
Division name Department of Respiratory Medicine, Allergy, and Rheumatic Diseases
Zip code
Address
TEL 06-6879-3833
Homepage URL
Email

Sponsor
Institute Osaka University Graduate School of Medicine,Department of Respiratory Medicine, Allergy, and Rheumatic Diseases
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 12 Month 03 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 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information epidemiology

Management information
Registered date
2009 Year 12 Month 03 Day
Last modified on
2009 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003461

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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