UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017454 |
|---|---|
| Receipt number | R000020231 |
| Scientific Title | A Randomized Controlled Trial of Saving Alcohol Amount Program for Keeping Optimal Blood Pressure Control in Patients with Hypertension |
| Date of disclosure of the study information | 2015/05/09 |
| Last modified on | 2020/01/26 16:03:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Randomized Controlled Trial of Saving Alcohol Amount Program for Keeping Optimal Blood Pressure Control in Patients with Hypertension
Acronym
OSAKE study
Scientific Title
A Randomized Controlled Trial of Saving Alcohol Amount Program for Keeping Optimal Blood Pressure Control in Patients with Hypertension
Scientific Title:Acronym
OSAKE study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a randomized controlled trials to examine the effects of alcohol reduction program intervention on blood pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Home morning blood pressure
Key secondary outcomes
1)Home evening blood pressure
2)Office blood pressure
3)Amount of alcohol consumption
4)Liver function(GOT,GPT,GGT),Lipid profiles(TC,TG,HDL,LDL), FBS ,HbA1c, UA
5)BMI, Abdominal circumference
6)Salt intake amount
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Education program for alcohol reduction by nurses
Interventions/Control_2
No Education program for alcohol reduction by nurses
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
| 75 | years-old | > |
Gender
Male
Key inclusion criteria
1) Essential hypertensive patients
2) The mean home morning blood pressure for five consecutive days is more than 135/85mmHg(includes the patients taking medication for hypertension)
3)Patients with alcohol drinking habit more than adequate amounts
Key exclusion criteria
1) Severe hypertension patients(home morning blood pressure more than 175/105 mmHg)
2) Alcoholic patients to be treated at the special hospital
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Kamide |
Organization
Osaka University Graduate School of Medicine
Division name
Division of Health Sciences
Zip code
5650871
Address
1-7 Yamadaoka,Suita,Osaka,Japan
TEL
06-6879-2551
kamide@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Kabayama |
Organization
Osaka University Graduate School of Medicine
Division name
Division of Health Sciences
Zip code
5650871
Address
1-7 Yamadaoka,Suita,Osaka,Japan
TEL
06-6879-2554
Homepage URL
kabayama@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Health Promotion Science,Division of Health Sciences,Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
2-2Yamadaoka Suita
Address
06-6210-8296
Tel
06-6210-8296
handai-nintei@hp-crc.med.osaka-u.ac.jp
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
| 2015 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
53
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
Main results already published
Date of protocol fixation
| 2015 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | 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
| 2015 | Year | 05 | Month | 07 | Day |
Last modified on
| 2020 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020231
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
