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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011276
Receipt No. R000013215
Scientific Title Efficacy of ARB and low dose diuretic combination in type 2 diabetics with hypertension
Date of disclosure of the study information 2013/07/25
Last modified on 2013/07/25

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Basic information
Public title Efficacy of ARB and low dose diuretic combination in type 2 diabetics with hypertension
Acronym Efficacy of ARB and low dose diuretic combination in type 2 diabetics with hypertension
Scientific Title Efficacy of ARB and low dose diuretic combination in type 2 diabetics with hypertension
Scientific Title:Acronym Efficacy of ARB and low dose diuretic combination in type 2 diabetics with hypertension
Region
Japan

Condition
Condition Type 2 diabetes mellitus with hypertension
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to assess the changes in blood pressure and metabolism resulting from switching treatment from maximum dose ARB therapy to a mixture of conventional dose ARB (losartan 50 mg) and low dose diuretic (hydrochlorothiazide 12.5 mg).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in blood pressure at 24 weeks
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Switching treatment from maximum dose ARB therapy to a mixture of conventional dose ARB (losartan 50 mg) and low dose diuretic (hydrochlorothiazide 12.5 mg).
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
80 years-old >
Gender Male and Female
Key inclusion criteria Diabetic patients with hypertension were enrolled whose blood pressure had not reached therapeutic target values for more than 12 weeks despite oral administration of maximum doses of ARB within the scope of treatment covered by medical insurance in Japan. Target blood pressure was set at a systolic blood pressure of 130 mmHg or lower and a diastolic blood pressure 80 mmHg or lower.
Key exclusion criteria Patients using uric acid lowering medication, patients with heart failure, and patients with severe liver and kidney dysfunction.
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yoshiya Tanaka
Organization School of Medicine, University of Occupational and Environmental Health
Division name First Department of Internal Medicine
Zip code
Address 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization School of Medicine, University of Occupational and Environmental Health
Division name First Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email sunao-y@med.uoeh-u.ac.jp

Sponsor
Institute First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2013 Year 07 Month 25 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
2008 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 25 Day
Last modified on
2013 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013215

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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