UMIN-CTR Clinical Trial

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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