UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027639 |
|---|---|
| Receipt number | 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 15:36:35 |
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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
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
hayashit@otsuka.jp
Public contact
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
hayashit@otsuka.jp
Sponsor or person
Institute
Medical Affairs Department
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031634
