Unique ID issued by UMIN | UMIN000004750 |
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Receipt number | R000005655 |
Scientific Title | The study of efficacy of AT1 receptor blocker, olmesartan and calcium antagonists , azelnidipine combination therapy in patients with essential hypertension , diabetic or chronic kidney disease |
Date of disclosure of the study information | 2010/12/18 |
Last modified on | 2012/01/18 14:12:49 |
The study of efficacy of AT1 receptor blocker, olmesartan and calcium antagonists ,
azelnidipine combination therapy in patients with essential hypertension , diabetic or chronic kidney disease
The study of efficacy of AT1 receptor blocker, olmesartan and calcium antagonists ,
azelnidipine combination therapy in patients with essential hypertension , diabetic or chronic kidney disease
(HARIMAYA study)
The study of efficacy of AT1 receptor blocker, olmesartan and calcium antagonists ,
azelnidipine combination therapy in patients with essential hypertension , diabetic or chronic kidney disease
The study of efficacy of AT1 receptor blocker, olmesartan and calcium antagonists ,
azelnidipine combination therapy in patients with essential hypertension , diabetic or chronic kidney disease
(HARIMAYA study)
Japan |
Patient with essential hypertension, diabetic or chronic kidney disease
Endocrinology and Metabolism | Nephrology |
Others
NO
It is a purpose to confirm the antihypertensive effect and safety of olmesartan and azelnidipine combination therapy in patients with essential hypertension , diabetic or chronic kidney disease
Efficacy
Pragmatic
Not applicable
The change from baseline in BP
(office blood pressure, home blood pressure)
The proportion of patients achieving the BP goal provided by the guideline for the management of hypertension in Japan
The change from baseline of protein in urine and eGFR
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
It changes from therapy of conventional dose of ARB or CCB to combination therapy of olmesartan (20mg/day) and azelnidipine (16mg/day).
Target blood pressure (BP) is under 130/80 mmHg
Not applicable |
Not applicable |
Male and Female
Patients with essential hypertension , diabetic or chronic kidney disease.
Patients are taking conventional dose of AT1 receptor blocker or calcium antagonists.
SBP/DBP > 130/80mmHg
Patients who meets the above-mentioned requirement.
SCr > 3.0mg/dl
Patient has liver dysfunction.
It is a developing patient within six months as for cardiac infarction or the apoplexy.
Patient who has possibility of pregnancy or pregnancy.
Patient while suckling.
Patient who judged that doctor is improper
200
1st name | |
Middle name | |
Last name | Yoshio Terada |
Kochi Medical School
Department of Endocrinology, Metabolism and Nephrology
Kohasu, Oko-cho, Nankoku, Japan
088-880-2343
1st name | |
Middle name | |
Last name | Koji Ogata |
Kochi Medical School
Department of Endocrinology, Metabolism and Nephrology
Kohasu, Oko-cho, Nankoku, Japan
088-880-2343
b08d6b06@s.kochi-u.ac.jp
Kochi Medical School
None
Self funding
NO
2010 | Year | 12 | Month | 18 | Day |
Unpublished
Enrolling by invitation
2010 | Year | 09 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2010 | Year | 12 | Month | 18 | Day |
2012 | Year | 01 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005655
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