Unique ID issued by UMIN | UMIN000008615 |
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Receipt number | R000010126 |
Scientific Title | A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD). |
Date of disclosure of the study information | 2012/08/04 |
Last modified on | 2016/02/04 15:03:54 |
A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).
A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).
A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).
A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).
Japan |
Hypertension
Chronic kidney disease
Medicine in general | Cardiology | Nephrology |
Others
NO
This study compares effects of direct renin inhibitor aliskiren and AT1 receptor blocker (ARB) on blood pressure lowering, renal protection, ROS reduction and safety aspects in hypertensive patients with chronic kidney disease who are already treated with standard dose of ARB.
Safety,Efficacy
1. BW, obesity, abdominal circumference
2. Clinical blood pressure
3. Home blood pressure
4. ABPM
5. Renal function (urinary protein/albumin/Cr excretion, BUN, eGFR, uric acid, L-FABP)
6. Vascular function(AI, ABI/baPWV), CAVI, FMD)
7. Sympathetic nerve activity
8. Glucose metabolism (FBS, HbA1C, IRI, HOMA-IR)
9. Lipid metabolism (TCHO, LDLC, HDLC, TG)
10.Endocrine (PRA, PAC, urinary aldosteron concentration, BNP)
11.Oxidative stress (h-s CRP, serum pentosidine)
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 |
Direct renin inhibitor group: Patients are initially given 150-300 mg of aliskiren once daily for 24 weeks.
ARB group: Patients are initially given standard dose of ARB once daily for 24 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1. Hypertensive patients with CKD G1-G4.
2. Patients who are already receiving antihypertensive therapy including ARB.
1. CKD G5, or dialysis patients.
2. History of hypersensitivity to ARB and/or aliskiren.
3. Pregnant women and/or women who are suspect of pregnancy.
4. Patients taking cyclosporin and/or itraconazole.
Patients with history of angioedema
5. Patients judged as inappropriate for the study.
100
1st name | |
Middle name | |
Last name | Kouichi TAMURA |
Yokohama City University School of Medicine
Department of Cardiorenal 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 Cardiorenal 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
2012 | Year | 08 | Month | 04 | Day |
Published
Completed
2012 | Year | 08 | Month | 01 | Day |
2012 | Year | 08 | Month | 01 | Day |
2015 | Year | 08 | Month | 31 | Day |
2015 | Year | 08 | Month | 31 | Day |
2015 | Year | 11 | Month | 30 | Day |
2012 | Year | 08 | Month | 04 | Day |
2016 | Year | 02 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010126
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