UMIN-CTR Clinical Trial

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
Email	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
Email	kabayama@sahs.med.osaka-u.ac.jp

Sponsor
Institute	Department of Health Promotion Science,Division of Health Sciences,Osaka University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020231