UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survey on the Issue of Alcohol Dependence in Patients with Hypertension Having a Drinking Habit who Consult Internists
Title of the study (Brief title)	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
Name of lead principal investigator	Takako Hayashi
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Medical Affairs Department
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
Name of contact person	Takako Hayashi
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Medical Affairs Department
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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