UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011959 |
|---|---|
| Receipt number | R000013971 |
| Scientific Title | The effect of losartan/hydrochlorothiazide combination therapy on LV diastolic function in patients with uncontrolled hypertension in comparison with a high-dose losartan therapy |
| Date of disclosure of the study information | 2013/10/04 |
| Last modified on | 2013/10/04 19:17:25 |
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Basic information
Public title
The effect of losartan/hydrochlorothiazide combination therapy on LV diastolic function
in patients with uncontrolled hypertension in comparison with a high-dose losartan therapy
Acronym
The effect of losartan/hydrochlorothiazide combination therapy on LV diastolic function in patients with hypertension
Scientific Title
The effect of losartan/hydrochlorothiazide combination therapy on LV diastolic function
in patients with uncontrolled hypertension in comparison with a high-dose losartan therapy
Scientific Title:Acronym
The effect of losartan/hydrochlorothiazide combination therapy on LV diastolic function in patients with hypertension
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of the combination therapy of losartan and hydrochlorothiazide on LV diastolic function compared with high-dose losartan therapy in patients with uncontrolled hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
E/E' in echocardiography, BNP
Key secondary outcomes
MMP-2, MMP-9, TIMP-1, TIMP-2
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
losartan (50mg/day) + HCTZ (12.5mg/day)
Interventions/Control_2
losartan (100mg/day)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
uncontrolled hypertensive patients (BP>140/90 mmHg) treated by losartan (50mg/day) with LV diastolic dysfunction (15<=E/E' OR 8<=E/E'<15 & 200<BNP)
Key exclusion criteria
LV systolic dysfunction (EF<50%)
liver dysfunction (AST or ALT>=100)
renal dysfunction (eGFR<30)
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhide Ogino |
Organization
Tottori University Hospital
Division name
Division of Clinical Laboratory
Zip code
Address
36-1 Nishicho, Yonago 683-8504, Japan
TEL
0859-38-6792
ko-36@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhide Oginio |
Organization
Tottori University Hospital
Division name
Division of Clinical Laboratory
Zip code
Address
36-1 Nishicho, Yonago 683-8504, Japan
TEL
0859-38-6792
Homepage URL
ko-36@umin.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
鳥取大学医学部附属病院（鳥取県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 04 | 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
The combination therapy decreased BNP level, however, the high-dose losartan therapy did not.
The combination therapy decreased E/E', however, the high-dose therapy did not.
The combination therapy decreased MMP-2 level, however, the high-dose therapy did not.
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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 04 | Day |
Last modified on
| 2013 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013971
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
