Unique ID issued by UMIN | UMIN000001692 |
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Receipt number | 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 | 2020/02/17 08:52:45 |
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.
Effects of Losartan and diUretics Combination therapy on Intensive blood pressure control and DiAbetic Tolerance in East-Saitama(ELUCIDATE)
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.
Effects of Losartan and diUretics Combination therapy on Intensive blood pressure control and DiAbetic Tolerance in East-Saitama(ELUCIDATE)
Japan |
Hypertension
Medicine in general | Endocrinology and Metabolism |
Others
NO
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.
Efficacy
Confirmatory
Explanatory
Phase IV
Changes in blood pressure after 8 weeks.
The achievement rate of the blood pressure target level(JSH criteria)after 8 weeks
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Fixed dose of Losartan/HCTZ group
ARB and CCB combination group
20 | years-old | <= |
85 | years-old | > |
Male and Female
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
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
300
1st name | |
Middle name | |
Last name | Toshihiko Inukai |
Koshigaya Hospital,
Dokkyo Medical University
Department of Internal Medicine
2-1-50,Minanikoshigaya,Koshigaya-city,Saitama,343-8555,Japan
048-965-8253
t-inukai@dokkyomed.ac.jp
1st name | |
Middle name | |
Last name | Yoshimasa Aso |
Koshigaya Hospital,Dokkyo Medical University
Department of Internal Medicine
2-1-50,Minanikoshigaya,Koshigaya-city,Saitama,343-8555,Japan
048-965-8253
yaso@dokkyomed.ac.jp
Hypertension and Metabolism Study group in East Saitama
The Waksman Foundation of Japan Inc
Non profit foundation
Japan
NO
2009 | Year | 02 | Month | 06 | Day |
Unpublished
Completed
2008 | Year | 12 | Month | 01 | Day |
2009 | Year | 02 | Month | 20 | Day |
2009 | Year | 03 | Month | 01 | Day |
2013 | Year | 08 | Month | 12 | Day |
2018 | Year | 10 | Month | 12 | Day |
2018 | Year | 10 | Month | 12 | Day |
2018 | Year | 10 | Month | 12 | Day |
2009 | Year | 02 | Month | 06 | Day |
2020 | Year | 02 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002041
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