Unique ID issued by UMIN | UMIN000001593 |
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Receipt number | R000001895 |
Scientific Title | Therapeutic effects of L/N type calcium channel blocker cilnidipine and L type calcium channel blockers on hypertensive patients with chronic kidney disease |
Date of disclosure of the study information | 2008/12/22 |
Last modified on | 2015/06/19 09:40:17 |
Therapeutic effects of L/N type calcium channel blocker cilnidipine and L type calcium channel blockers on hypertensive patients with chronic kidney disease
Therapeutic effects of L/N type calcium channel blocker cilnidipine and L type calcium channel blockers on hypertensive patients with chronic kidney disease
Therapeutic effects of L/N type calcium channel blocker cilnidipine and L type calcium channel blockers on hypertensive patients with chronic kidney disease
Therapeutic effects of L/N type calcium channel blocker cilnidipine and L type calcium channel blockers on hypertensive patients with chronic kidney disease
Japan |
Hypertension, Chronic kidney disease
Medicine in general | Cardiology | Endocrinology and Metabolism |
Nephrology |
Others
NO
This study will compare L/N type calcium channel blocker cilnidipine with other L type calcium channel blockers concerning blood pressure profile including blood pressure levels, diurnal blood pressure rhythm, renal function, autonomic nerve activity, and markers of oxidative stress in hypertensive patients with chronic kidney disease who are already treated with inhibitors of renin-angiotensin system and calcium channel blockers other than cilnidipine.
Efficacy
Confirmatory
Pragmatic
Phase IV
1. Clinic blood pressure.
2. Ambulatory blood pressure monitoring.
3. Renal function: eGFR, urinary protein/albuminon excretion.
4. Renin-angiotensin system, inflammatory and oxidative stress markers, PRA, urinary angiotensinogen, plasma cathecholamine.
5. Cardiac function: BNP, UCG.
6. Vascular function: ABI/baPWV.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Cilnidipine (L/N) group: Change already prescribed calcium channel blockers other than cilnidipine to daily dosing of cilnidipine 10 mg daily for 48 weeks, and dosage may be modulated accroding to the clinical parameters (cilnidipine 5-20 mg daily). Target blood pressure level is below 130/80 mmHg.
Control (L) group: Continue already prescribed calcium channel blockers other than cilnidipine for 48 weeks, and dosage may be modulated accroding to the clinical parameters. Target blood pressure level is below 130/80 mmHg.
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with chronic kidney disease stages 3, 4, and 5 (eGFR<=60 ml/min/1.73 m2),
2. who are already treated with inhibitors of renin-angiotensin system (ACEi and/or ARB),
3. and are also already treated with calcium channel blockers other than cilnidipine.
1. Patients already treated with cilnidipine,
2. History of hypersensitivity to cilnidipine,
3. Severe hypertension (clinic BP more than 180/100 mmHg),
4. Severe liver disorder, or severe biliary atresia,
5. Pregnant women, or women suspected of being pregnant.
60
1st name | |
Middle name | |
Last name | Kouichi TAMURA |
Yokohama City University Graduate School of Medicine
Deaprtment of Medical Science
3-9 Fukuura, kanazawa-ku, Yokohama 236-0004, Japan
045-787-2635
1st name | |
Middle name | |
Last name | Satoshi UMEMURA |
Yokohama City University Graduate School of Medicine
Deaprtment of Medical Science
3-9 Fukuura, kanazawa-ku, Yokohama 236-0004, Japan
045-787-2633
sumemura@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
NO
2008 | Year | 12 | Month | 22 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/23959116
Completed
2008 | Year | 12 | Month | 19 | Day |
2008 | Year | 12 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2015 | Year | 03 | Month | 01 | Day |
2008 | Year | 12 | Month | 19 | Day |
2015 | Year | 06 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001895
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