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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001692
Receipt No. R000002041
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.
Date of disclosure of the study information 2009/02/06
Last modified on 2018/10/12

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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 Open public recruiting
Date of protocol fixation
2008 Year 12 Month 01 Day
Date of IRB
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
2018 Year 10 Month 12 Day


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

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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