UMIN-CTR Clinical Trial

Basic information
Public title	Comparing anti-hypertensive combination therapy of fixed dose losartan and hydrochlorothiazide(HCTZ) versus angiotensin receptor blocker(ARB) and calcium channel blocker(CCB) on hypertensive patients whose blood pressures don't lower enough,effect and influence of metabolic system trial.
Acronym	Effects of Losartan and diUretics Combination therapy on Intensive blood pressure control and DiAbetic Tolerance in East-Saitama(ELUCIDATE)
Scientific Title	Comparing anti-hypertensive combination therapy of fixed dose losartan and hydrochlorothiazide(HCTZ) versus angiotensin receptor blocker(ARB) and calcium channel blocker(CCB) on hypertensive patients whose blood pressures don't lower enough,effect and influence of metabolic system trial.
Scientific Title:Acronym	Effects of Losartan and diUretics Combination therapy on Intensive blood pressure control and DiAbetic Tolerance in East-Saitama(ELUCIDATE)
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare fixed dose combination losartan/HCTZ with combination therapies of ARB and CCB regarding lowering blood pressure effect and safety,especially ifluence of metabolic makers in hypertensive patients whose blood pressures don't lower enough.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Changes in blood pressure after 8 weeks. The achievement rate of the blood pressure target level(JSH criteria)after 8 weeks
Key secondary outcomes	Inhibitory effect of development of diabetes. The rate of new-onset diabetes. Change in blood pressure,blood glucose,HbA1c,high-molecular weight adiponectin,hs-CRP,BNP,urinary microalbuminuria. Safty

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Fixed dose of Losartan/HCTZ group
Interventions/Control_2	ARB and CCB combination group
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Hypertensive patients, who have been previously treated with monotherapy of an ARB for more than 4 weeks, however, whose blood pressure has not been reached the target defined by the JSH2009 criteria. 2) Men and women aged from 20 to 85 years 3) Outpatients 4) Patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to participate in the study
Key exclusion criteria	1)Patients with uncontrolled diabetes (HbA1c more than 9.0%) 2) Patients with secondary hypertension 3)Patients who have stroke, AMI and/or other critical vascular complications that required hospitalization within 24 weeks prior to the intervention 4)Patients with liver dysfunction [GPT(ALT) over three times the normal value] 5)Patients with renal failure (serum creatinine more than 2.0 mg/dL) 6)Patients with uncontrolled hyperuricemia (more than 9.0mg/dL) 7)Patients with cardiac insufficiency (more than NYHA grade III) 8) Patients with severe malignant cancer or other unfavorable prognostic factors 9)Pregnant or possible pregnant women 10)Patients with a history of hypersensitivity to ingredients of losartan potassium or hydrochlorothiazide 11)Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics 12)Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toshihiko Inukai
Organization	Koshigaya Hospital, Dokkyo Medical University
Division name	Department of Internal Medicine
Zip code
Address	2-1-50,Minanikoshigaya,Koshigaya-city,Saitama,343-8555,Japan
TEL	048-965-8253
Email	t-inukai@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshimasa Aso
Organization	Koshigaya Hospital,Dokkyo Medical University
Division name	Department of Internal Medicine
Zip code
Address	2-1-50,Minanikoshigaya,Koshigaya-city,Saitama,343-8555,Japan
TEL	048-965-8253
Homepage URL
Email	yaso@dokkyomed.ac.jp

Sponsor
Institute	Hypertension and Metabolism Study group in East Saitama
Institute
Department

Funding Source
Organization	The Waksman Foundation of Japan Inc
Organization
Division
Category of Funding Organization	Non profit foundation
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

Other administrative information
Date of disclosure of the study information	2009 Year 02 Month 06 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 12 Month 01 Day
Date of IRB	2009 Year 02 Month 20 Day
Anticipated trial start date	2009 Year 03 Month 01 Day
Last follow-up date	2013 Year 08 Month 12 Day
Date of closure to data entry	2018 Year 10 Month 12 Day
Date trial data considered complete	2018 Year 10 Month 12 Day
Date analysis concluded	2018 Year 10 Month 12 Day

Other
Other related information

Management information
Registered date	2009 Year 02 Month 06 Day
Last modified on	2020 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002041