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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011959
Receipt No. 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

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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
Email 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
Email ko-36@umin.ac.jp

Sponsor
Institute Tottori University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013971

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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