UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017820 |
|---|---|
| Receipt number | R000018340 |
| Scientific Title | The effects of thiazide diuretics or calcium channel blockers on blood pressure and glycemic controls in hypertensive patients with type 2 diabetes |
| Date of disclosure of the study information | 2015/06/05 |
| Last modified on | 2015/06/05 01:42:15 |
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Basic information
Public title
The effects of thiazide diuretics or calcium channel blockers on blood pressure and glycemic controls in hypertensive patients with type 2 diabetes
Acronym
The losartan drug combination study
Scientific Title
The effects of thiazide diuretics or calcium channel blockers on blood pressure and glycemic controls in hypertensive patients with type 2 diabetes
Scientific Title:Acronym
The losartan drug combination study
Region
| Japan |
Condition
Condition
Type 2 diabetic hypertensive patients
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We performed this study to evaluate the effects on blood pressure reduction and glycemic control by adding thiazide diuretics or CCB to basal use of RAS inhibitor in Type 2 diabetic hypertensive patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endpoints were blood pressure and glycemic control. We accessed the systolic and diastolic blood pressure level at two and four months. To evaluate glycemic control the HbA1c, fasting plasma glucose, and serum IRI values at two and four months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To switch to the losartan 50 mg/HCTZ 12.5 mg drug combination from single use of lsartan 50 mg
Interventions/Control_2
To add the amlodipine 5 mg to basal use of Losartan 50 mg
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were (1) age > 20; (2) systolic blood pressure > 130 mmHg, or diastolic blood pressure > 80 mmHg; (3) patients who had already taken losartan for more than six months.
Key exclusion criteria
Exclusion criteria were (1) HbA1c > 8.0%; (2) the patients who had episodes of myocardial infarction or stroke within six months from the onset of this study; (3) heart failure; (4) past history of hyperuricemia, or uric acid level at baseline > 8.0 mg/dL; (5) kidney dysfunction (serum creatinine > 2.0 mg/dL); (6) secondary or malignant hypertension; or (7) kidney disease not caused by diabetic nephropathy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuko Uchigata |
Organization
Tokyo Women's Medical University School of Medicine
Division name
Diabetes Center
Zip code
Address
8-1 kawada-cho, Shinjuku, Tokyo
TEL
03-3353-8111
uchigata@dmc.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Babazono |
Organization
Tokyo Women's Medical University School of Medicine
Division name
Diabetes Center
Zip code
Address
8-1 kawada-cho, Shinjuku, Tokyo
TEL
03-3353-8111
Homepage URL
babazono@dmc.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Kidney 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
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
| 2015 | 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
| 2007 | Year | 10 | Month | 30 | 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
| 2015 | Year | 06 | Month | 05 | Day |
Last modified on
| 2015 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018340
| 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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