UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011276 |
|---|---|
| Receipt number | 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 20:40:16 |
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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
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
Public contact
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
sunao-y@med.uoeh-u.ac.jp
Sponsor or person
Institute
First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013215
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
