Unique ID issued by UMIN | UMIN000013213 |
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Receipt number | R000015416 |
Scientific Title | Effect of on combination therapy with irbesartan and amlodipine besilate on clinical blood pressure, home blood pressure and blood pressure variability in hypertensive patients with chronic kidney disease |
Date of disclosure of the study information | 2014/02/21 |
Last modified on | 2014/02/21 14:17:02 |
Effect of on combination therapy with irbesartan and amlodipine besilate on clinical blood pressure, home blood pressure and blood pressure variability in hypertensive patients with chronic kidney disease
Effect of combination therapy with irbesartan and amlodipine besilate on hypertensive patients with chronic kidney disease
Effect of on combination therapy with irbesartan and amlodipine besilate on clinical blood pressure, home blood pressure and blood pressure variability in hypertensive patients with chronic kidney disease
Effect of combination therapy with irbesartan and amlodipine besilate on hypertensive patients with chronic kidney disease
Japan |
Hypertension with chronic kidney disease (CKD G1-G4)
Medicine in general | Nephrology |
Others
NO
We aim to elucidate the effect of combination therapy with long-acting calcium channel blocker amlodipine besilate and long-acting AT1 receptor blocker irbesartan in hypertensive patients with chronic kidney disease. Especially, we evaluate clinical blood pressure, home blood pressure and blood pressure variability.
Safety,Efficacy
Efficacy: Change in the following from baseline to Week 4,8,12:
-Clinical blood pressure, within visit blood pressure variability
-Home blood pressure, home blood pressure variability
-Nighttime blood pressure, nighttime blood pressure variability
Efficacy: Change in the following from baseline to Week 12:
-Body weight, obesity, abdominal circumference
-Laboratory parameters (renal function, oxidative stress etc.)
-Vascular function (AI, ABI/PWV, CAVI)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Irbesartan / amlodipine besilate combination tablets
20 | years-old | <= |
Not applicable |
Male and Female
1) CKD G1-G4.
2) Under the antihypertensive therapy (standard doses of RAS inhibitor or Calcium channel blocker).
3) Blood pressure at hospital visit: Systolic blood pressure is 130 mmHg or higher, or diastolic blood pressure is 80 mmHg or higher.
1) CKD G5 or dialysis patients.
2) Patients who have allergy for amlodipine besilate or irbesartan.
3) Patients who are pregnant.
4) Patients judged as inappropriate for the study.
30
1st name | |
Middle name | |
Last name | Kouichi Tamura |
Yokohama City University School of Medicine
Department of Cadiorenal Medicine
3-9 Fukuura Kanazawa-ku, Yokohama 236-0004, Japan
045-787-2635
tamukou@med.yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Kouichi Tamura |
Yokohama City University School of Medicine
Department of Cadiorenal Medicine
3-9 Fukuura Kanazawa-ku, Yokohama 236-0004, Japan
045-787-2635
tamukou@med.yokohama-cu.ac.jp
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Self
Self funding
JAPAN
NO
横浜市立大学附属病院
2014 | Year | 02 | Month | 21 | Day |
Unpublished
Open public recruiting
2013 | Year | 02 | Month | 01 | Day |
2013 | Year | 08 | Month | 01 | Day |
2018 | Year | 01 | Month | 31 | Day |
2014 | Year | 02 | Month | 21 | Day |
2014 | Year | 02 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015416
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