Unique ID issued by UMIN | UMIN000006821 |
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Receipt number | R000008069 |
Scientific Title | Comparison of effects of aliskiren-based combination therapy between CCB and ARB in hypertensive patients with chronic kidney disease |
Date of disclosure of the study information | 2011/12/02 |
Last modified on | 2012/07/03 13:28:43 |
Comparison of effects of aliskiren-based combination therapy between CCB and ARB in hypertensive patients with chronic kidney disease
Comparison of effects of aliskiren-based combination therapy between CCB and ARB in hypertensive patients with chronic kidney disease
Comparison of effects of aliskiren-based combination therapy between CCB and ARB in hypertensive patients with chronic kidney disease
Comparison of effects of aliskiren-based combination therapy between CCB and ARB in hypertensive patients with chronic kidney disease
Japan |
Hypertension, chronic kidney disease
Medicine in general | Cardiology | Endocrinology and Metabolism |
Nephrology | Clinical immunology | Geriatrics |
Others
NO
This will compare the beneficial or adverse effects of aliskiren (150 mg daily)-based combination therapy with CCB amlodipine (2.5-10 mg daily) and ARB valsartan (40-160 mg daily) on clinic BP, ambulatory BP profile, vascular and kidney function, and oxidative stress and metabolic markers, in hypertensive patients with chronic kidney disease who do not achieve the target BP that is recommended by JSH2009 guideline and CKD guideline 2009.
Safety,Efficacy
Confirmatory
Explanatory
Phase IV
1. Body weight, BMI, abdominal circumference.
2. Clinic BP
3. Home BP
4. Ambulatory BP
5. Renal function (eGFR), urinary protein and albumin excretion, urinary sodium excretion. Urinary type IV collagen and angiotensinogen.
6. Vascular function. Central BP, ABI/PWV, FMD.
7. Glucose metabolism markers.
8. Lipid metabolism markers.
9. Endocrine system. PRA, PAC, BNP.
10. Inflammatory and oxidative stress markers.
Interventional
Parallel
Randomized
Open -but assessor(s) are blinded
Active
YES
NO
Institution is not considered as adjustment factor.
2
Treatment
Medicine |
CCB group:
In the intervention phase, add-on combination therapy will be performed by amlodipine 2.5-10 mg daily for 24 weeks.
ARB group:
In the intervention phase, add-on combination therapy will be performed by valsartan 40-160 mg daily for 24 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1) Chronic kidney disease.3)
2) On monotherapy by aliskiren 150 mg daily.
3) Clinic SBP >= 130 mmHg or clinic DBP>=80 mmHg.
1) CKD stage 5 or on dialysis therapy
2) History of hypersensitivity to aliskiren, amlodipine, or valsartan.
3) Pregnant or suspicious women.
4) Treatment with itraconazole, cyclosporine.
5) Judged as inappropriate for the study
100
1st name | |
Middle name | |
Last name | KOUICHI TAMURA |
Yokohama City University Graduate School of Medicine
Department of Medical Science and Cardiorenal Medicine
3-9 Fukuura, Kanazawa-ku, Yokohama 2360004, Japan
045-787-2635
1st name | |
Middle name | |
Last name | Kouichi Tamura |
Yokohama City University Graduate School of Medicine
Department of Medical Science and Cardiorenal Medicine
3-9 Fukuura, Kanazawa-ku, Yokohama 2360004, Japan
045-787-26358
tamukou@med.yokohama-cu.ac.jp
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Self funding
JAPAN
NO
横浜市立大学附属病院(神奈川県)
2011 | Year | 12 | Month | 02 | Day |
Unpublished
Terminated
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2017 | Year | 12 | Month | 01 | Day |
2018 | Year | 12 | Month | 01 | Day |
2019 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 02 | Day |
2012 | Year | 07 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008069
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