Unique ID issued by UMIN | UMIN000003978 |
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Receipt number | R000004729 |
Scientific Title | Nagasaki Investigation of Candesartan Effects -the Comparison Between an Increased Candesartan and the additional Diuretics- |
Date of disclosure of the study information | 2010/08/07 |
Last modified on | 2013/02/03 09:50:56 |
Nagasaki Investigation of Candesartan Effects
-the Comparison Between an Increased Candesartan and the additional Diuretics-
NICE-C
Nagasaki Investigation of Candesartan Effects
-the Comparison Between an Increased Candesartan and the additional Diuretics-
NICE-C
Japan |
Hypertension
Cardiology |
Others
NO
The aim of this study is to examine the differences of the organ protective effects by between increased dose of candesartan to 12mg/day and the additional administration of hydrochlorothiazide, 6.25mg/day, in hypertensive patients taking candesartan of 8mg/day.
Efficacy
Confirmatory
Pragmatic
Not applicable
Changes in blood pressure values in outpatient clinic.
Changes in the levels of urine microalbumin, NT-proBNP, high-sensitive CRP, and HbA1c.
Flow mediated dilation
Augmentation index
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Administration of dose-up of candesartan (from 8mg to 12mg/day) for 6 months
Additional adminstration of 6.25mg/day of hydrochlorothiazide for 6 months
40 | years-old | <= |
Not applicable |
Male and Female
Patients with essential hypertension who has the insufficient values of blood pressure under taking antihypertensive agents except diuretics and additional administration of 8mg/day of candesartan for at least 3 months are enrolled.
Incrusion criteria included the following:
(1)Patients in outpatient clinic
(2)Male or female of more than 40 years
(3)Patients with more than 135 mmHg in systolic blood pressure or 85 mmHg in diastolic blood pressure on 2 times of most recent measurements of blood pressure at sitting position
(4)Patients who agreed to attend to this study
Exclusion criteria comprised any of the following:
(1)Patients under treatments with antihypertensive agents except diuretics who will not continue to take 8mg/day of candesartan for at least 3 months.
(2)Administration of diuretics or of agents influencing rennin-angiotensin-aldosterone system except for candesartan.
(3)Concomitant medications which are expected to be frequently changed.
(4)Under treatment of insulin for diabetes.
(5)Severe renal dysfunction (eGFR<30 mL/min/1.73m2)
(6)Heart failure (NYHA classification III or IV)
(7)Malignant hypertension and secondary hypertension.
(8)Myocardial infarction, stroke, and revascularization therapies of coronary arteries and/or peripheral arteries within 6 months prior to the registration of this study.
(9)Pregnant female
(10)Allergic disorder which is problem in the clinical setting. Hypersensitivity or contraindication to candesartan or hydrochlorothiazide.
(11)Patients who are judged by doctors as inappropriate patients for the entries of this study
100
1st name | |
Middle name | |
Last name | Koji Maemura |
Nagasaki University Graduate School of Biomedical Sciences
Department of Cardiovascular Medicine
1-7-1 Sakamoto, Nagasaki, Japan
095-819-7288
1st name | |
Middle name | |
Last name | Satoshi Ikeda |
Nagasaki University Graduate School of Biomedical Sciences
Department of Cardiovascular Medicine
1-7-1 Sakamoto, Nagasaki, Japan
095-819-7288
sikeda@nagasaki-u.ac.jp
Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences
None
Self funding
Japan
NO
長崎大学病院(長崎県)、えぐち内科ステーションクリニック(長崎県)、嬉野医療センター(佐賀県)、川棚医療センター(長崎県)、久保内科病院(長崎県)、佐世保市立総合病院(長崎県)、佐世保中央病院(長崎県)、千住病院(長崎県)、北松中央病院(長崎県)、長崎労災病院(長崎県)
2010 | Year | 08 | Month | 07 | Day |
Unpublished
Terminated
2010 | Year | 06 | Month | 07 | Day |
2010 | Year | 08 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2010 | Year | 08 | Month | 02 | Day |
2013 | Year | 02 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004729
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