Unique ID issued by UMIN | UMIN000003936 |
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Receipt number | R000004732 |
Scientific Title | Therapeutic effects of direct renin inhibitor aliskiren on ambulatory blood pressure profile in essential hypertensives |
Date of disclosure of the study information | 2010/07/21 |
Last modified on | 2015/09/21 23:09:10 |
Therapeutic effects of direct renin inhibitor aliskiren on ambulatory blood pressure profile in essential hypertensives
Therapeutic effects of direct renin inhibitor aliskiren on ambulatory blood pressure profile in essential hypertensives
Therapeutic effects of direct renin inhibitor aliskiren on ambulatory blood pressure profile in essential hypertensives
Therapeutic effects of direct renin inhibitor aliskiren on ambulatory blood pressure profile in essential hypertensives
Japan |
Essential hypertension
Medicine in general | Cardiology | Endocrinology and Metabolism |
Nephrology |
Others
NO
We examine the effects of direct renin inhibitor aliskiren on office blood pressure, ambulatory blood pressure profile, aortic blood pressure, and laboratory parameters in essential hypertensives with and without type 2 diabetes.
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
1) Office blood pressure: -2, 0, 4, 8, and 12 wks.
2) Ambulatory blood pressure profile, aortic blood pressure (non-invasive central blood pressure), baPWV: 0 and 12 wks.
3) Urinalysis and blood analysis:
Urine; protein, albumin, creatinine.
Blood; complete blood count, total protein, albumin, blood urea nitrogen, creatinine, uric acid, electrolyte, AST, ALT, ALP, LDH, CK, T-bil, fasting blood glucose, IRI, HOMA-IR, HbA1c, T-cho, LDL-cho, HDL-cho, TG, high-sensitivity CRP, BNP, plasma renin activity, aldosterone concentration.
4) Adverse events: 4, 8, and 12 wks.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Essential hypertensives
20 | years-old | <= |
80 | years-old | > |
Male and Female
1. Essential hypertensives who are untreated more than 1 month.
2. Office systolic blood pressure >= 140 mmHg and <180 mmHg, or office diastolic blood pressure >= 90 mmHg and < 110 mmHg.
3. Informed consent is obtained.
1. Office systolic blood pressure >= 180 mmHg, or office diastolic blood pressure >= 110 mmHg.
2. Heart disease, cerebrovascular disease, or ckronic kidney disease with urinary protein excretion >= 300 mg/g-cr or estimated GFR < 60 ml/min/1.73 m2.
3. Cyclosporin treatment.
4. History of hypersensitivity of aliskiren.
5. Pregnant women or women suspect of being pregnant.
6. Arrhythmia.
7. Secondary hypertension.
8. Patients ineligible for the study determined by doctors
40
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, Kanzawa-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 Graduate School of Medicine
Department of Medical Science and Cardiorenal Medicine
3-9 Fukuura, Kanzawa-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
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
2010 | Year | 07 | Month | 21 | Day |
Unpublished
Open public recruiting
2009 | Year | 12 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2014 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2017 | Year | 12 | Month | 01 | Day |
2010 | Year | 07 | Month | 21 | Day |
2015 | Year | 09 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004732
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