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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027639
Receipt No. R000031634
Scientific Title Survey on the Issue of Alcohol Dependence in Patients with Hypertension Having a Drinking Habit who Consult Internists
Date of disclosure of the study information 2017/06/05
Last modified on 2017/12/06

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Basic information
Public title Survey on the Issue of Alcohol Dependence in Patients with Hypertension Having a Drinking Habit who Consult Internists
Acronym Survey on the issue of alcohol dependence in patients with hypertension
Scientific Title Survey on the Issue of Alcohol Dependence in Patients with Hypertension Having a Drinking Habit who Consult Internists
Scientific Title:Acronym Survey on the issue of alcohol dependence in patients with hypertension
Region
Japan

Condition
Condition General adults
Classification by specialty
Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Calculate the background of alcohol dependence and suspected alcohol dependence in patients with hypertension having a drinking habit and issues in these patient population. In addition, calculate the percentage of alcohol dependence and suspected alcohol dependence in patients with hypertension having a drinking habit who consult internists.
Basic objectives2 Others
Basic objectives -Others Epidemiology
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1) Calculate the background of patients with hypertension as an alcohol-related disease and issues in this population.
2) Calculate the percentage of alcohol dependence and suspected alcohol dependence in patients with hypertension having a drinking habit who consult internists.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria
[Survey 1]
1)Persons who drink alcohol more than two to three times a week
2)Persons aged 20 years and older when giving informed consent

[Survey 2] Persons who underwent the Survey 1 and meet all of the following
1)Persons with alcohol dependence or those who scored 15 and above in the Alcohol Use Disorders Identification Test (AUDIT) (suspected alcohol dependence)
2)Persons currently receiving treatment for hypertension by internists
Key exclusion criteria None
Target sample size 20000

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takako Hayashi
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Medical Affairs Department
Zip code
Address Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8241, Japan
TEL +81-3-6361-7344
Email hayashit@otsuka.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takako Hayashi
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Medical Affairs Department
Zip code
Address Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8241, Japan
TEL +81-3-6361-7344
Homepage URL
Email hayashit@otsuka.jp

Sponsor
Institute Medical Affairs Department
Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Medical Affairs Department
Otsuka Pharmaceutical Co., Ltd.
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
2017 Year 06 Month 05 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 Completed
Date of protocol fixation
2017 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 02 Day
Last follow-up date
2017 Year 06 Month 18 Day
Date of closure to data entry
Date trial data considered complete
2017 Year 07 Month 24 Day
Date analysis concluded

Other
Other related information Study design;Cross sectional study

Outline of entry;We get informed consent from the person who was registered the panel of Macromill,Inc and who was suitable for eligible criteria. Close the Web site when the number of persons giving informed consent reaches 20,000 on a first-come-first-served basis.

Study period: from June 1st,2017 to June 30th,2017

Management information
Registered date
2017 Year 06 Month 05 Day
Last modified on
2017 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031634

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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