Unique ID issued by UMIN | UMIN000009549 |
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Receipt number | R000011204 |
Scientific Title | Azilsartan can restore circadian rhythm of the urinary sodium excretion |
Date of disclosure of the study information | 2012/12/14 |
Last modified on | 2017/11/03 23:06:36 |
Azilsartan can restore circadian rhythm of the urinary sodium excretion
Azilsartan & Sodium Balance
Azilsartan can restore circadian rhythm of the urinary sodium excretion
Azilsartan & Sodium Balance
Japan |
Chronic Kidney Disease (CKD)
Nephrology |
Others
NO
To investigate whether the increase in daytime natriuresis (UNaV) can precede the restoration of circadian BP rhythm
Pharmacodynamics
Exploratory
Pragmatic
Not applicable
To investigate whether night/day UNaV ratio reduce to <1.0 before the night/day BP ratio reduce to <0.9
GFR, Urinary excretion of albumin, potassium, chrolide, angiotensinogen and 8-OHdG, HF and LF/HF obtained by Holter ECG,safety
Circadian BP rhythm 1 year after treatment was also studied.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
oral administration of Azilsartan once in the morning
16 | years-old | <= |
Not applicable |
Male and Female
1. received medical care at Nagoya City University Hospital
2. UNaV of 85-120mmol/day at least 3 different times 4 wks before enrollement
3. CKD criteria based on K/DOQI
4. need for Azilsartan
5. documented informed concent
1. previous treatment with ARB, or diuretics 2 months before enrollment
2. change in the antihypertensive medication 2 months before enrollment
3. contraindication to Azilsartan (history of allergic reaction to it, bilateral renal artery stenosis)
4. presence or possibility of pregnancy/lactation
5. HbA1c >9.0 %
6. GOT >100, or GPT >85
7. endocrine hypertension
8. accelerated o r malignant hypertension (progressive renal dysfunction with diastolic BP of >120-130 mmHg
9. serious conditions with congestive heart failure, coronary diseases, arrhythmia or systemic diseases
10. nephrotic syndrome (serum albumin <2.5 g/dl)
11. any reason for ineligibility suggested by the attending doctor
40
1st name | |
Middle name | |
Last name | Michio FUKUDA |
Nagoya City University Hospital
Division of Nephrology
Nagoya 467-8601, Japan
81-52-853-8221
m-fukuda@med.nagoya-cu.ac.jp
1st name | |
Middle name | |
Last name | Michio FUKUDA |
Nagoya City University Hospital
Division of Nephrology
Nagoya 467-8601, Japan
81-52-853-8221
m-fukuda@med.nagoya-cu.ac.jp
Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences
Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences
Self funding
Japan
NO
名古屋市立大学病院 (Nagoya City University Hospital)
2012 | Year | 12 | Month | 14 | Day |
http://www.med.nagoya-cu.ac.jp/cr.dir/
Published
Twenty patients has been enrolled to the study.
Published on Physiological Report
Completed
2012 | Year | 12 | Month | 10 | Day |
2012 | Year | 12 | Month | 17 | Day |
2015 | Year | 12 | Month | 31 | Day |
2016 | Year | 07 | Month | 31 | Day |
2016 | Year | 08 | Month | 31 | Day |
2016 | Year | 08 | Month | 31 | Day |
2012 | Year | 12 | Month | 14 | Day |
2017 | Year | 11 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011204
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