Unique ID issued by UMIN | UMIN000001803 |
---|---|
Receipt number | R000002148 |
Scientific Title | Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial |
Date of disclosure of the study information | 2009/03/27 |
Last modified on | 2015/07/16 20:32:05 |
Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial
Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial (EVALUATE)
Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial
Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial (EVALUATE)
Japan |
Hypertensive patients with albuminuria under the treatment of the inhibitor of the renin-angiotension system (RAS)
Nephrology |
Others
NO
To evaluate the antialbuminuric effect of eplerenone (50 mg/day) by comparing the effects between eplerenone and placebo on change in urinary albumin/creatinine (Cr) ratio
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
Percent changes in urinary albumin/Cr ratio in first morning void urine from pretreatment period (average of 3 continuously-measured values) to 12 months of treatment
1. Urinary albumin/Cr ratio in first morning void urine: Absolute value, percent changes from pretreatment period to each period of treatment, etc.
2. Urinary liver-type free fatty acid-binding protein (L-FABP)
3. Office blood pressure (BP)
4. Serum Cr or estimated glomerular filtration rate (eGFR) calculated using the modified MDRD formula in the Japanese Society of Nephrology: eGFR (ml/min/1.73 m2) = 194 x age -0.287 x serum Cr - 1.094 (multiply by 0.739 in female)
5. Estimated urinary sodium (Na) excretion for a day: Estimated urinary Na excretion for 24 hours (mmol/day) =21.98x{[urinary Na (mEq/L) / urinary Cr (mg/L)] x [-2.04 x age + 14.89 x body weight (kg) +16.14 x height (cm) - 2244.45]}0.392
6. Cerebro-cardio-vascular events: cerebro-cardio-vascular death (fatal myocardial infarction, fatal heart failure, sudden death, fatal stroke, other cardiovascular death) and hospitalization due to cerebro-cardio-vascular disease (nonfatal myocardial infarction, angina, heart failure, cerebral bleeding, cerebral infarction, transient cerebral ischemic attack)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Placebo is added in patients under the treatment of the RAS inhibitor.
If BP does not reach to lower than 130/80 mmHg, other antihypertensive drug than aldosterone antagonist and inhibitor of RAS is added.
Eplerenone (50mg/day) is added in patients with the treatment of the RAS inhibitor.
If BP does not reach to lower than 130/80 mmHg, other antihypertensive drug than aldosterone antagonist and inhibitor of RAS is added.
20 | years-old | <= |
80 | years-old | > |
Male and Female
Patients to fulfill all the following condition can participate
1. Outpatient systolic BP is equal or more than130 mmHg and less than 180 mmHg, and/or outpatient diastolic BP is equal or more than 80 mmHg and less than 110 mmHg
2. Urinary albumin/Cr ratio in first morning void urine at pretreatment period (average of 3 continuously-measured values) is equal or more than 30 mg/g and less than 600 mg/g
3. Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) has been administered for more than 8 weeks when the interim registration is done
4. eGFR is equal or more than 50 mL/min/1.73m2.
5. Age is equal or more than 20 and less than 80 year-old
6. Written informed consent is obtained based on written and oral explanation of physician in charge
1. Hypertensive emergency that requires intravenous administration of antihypertensives
2. Aldosterone antagonist has been administered within 8 weeks when the interim registration is done
3. Administration of adrenocorticosteroidal drug, immunosuppressant or long-term (equal or more than 2 weeks) administration of non-steroid anti-inflammatory drugs (NSAID)
4. Serum potassium (K) is equal or more than 5.0 mEq/L
5. Fasting blood glucose is equal or more than 126 mg/dL or anti-diabetic drug is administered.
6. Severe liver damage (Child-Pugh Score: class C)
7. Sever heart failure (NYHA class is equal or more than III), severe arrhythmia (frequent ventricular or atrial extrasystole, prolonged ventricular tachycardia, atrial tachyrhythmia with severe tachycardia, atrial fibrillation or flutter with severe tachycardia, sick sinus syndrome with severe bradycardia, atrio-ventricular block with severe bradycardia), angina, or myocardial infarction within 6 months
8. Cerebrovascular disease occurs within 6 months
9. Pregnant, possible to be pregnant, or willing to be pregnant
10. Past history of severe side effect of aldosterone antagonist, ACE inhibitor or ARB
11. Supplementation of K or administration of K-sparing diuretics, itraconazole, ritonavir, or nelfinavir.
12. Patients who are inadequate by determination of physician in charge
340
1st name | |
Middle name | |
Last name | Toshiro Fujita |
University of Tokyo Graduate School of Medicine
Department of Nephrology and Endocrinology
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8165, Japan
03-5800-9735
toshiro.fujita@rcast.u-tokyo.ac.jp
1st name | |
Middle name | |
Last name | Katsuyuki Ando |
University of Tokyo Graduate School of Medicine
Department of Nephrology and Endocrinology
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8165, Japan
03-5800-9119
https://center.umin.ac.jp/islet/evaluate/
katsua-tky@umin.sc.jp
EVALUATE Project office
Pfizer Japan Inc.
Profit organization
Japan
NO
2009 | Year | 03 | Month | 27 | Day |
http://evaluate.umin.jp/
Published
http://www.u-tokyo.ac.jp/public/public01_261028_j.html
Main results already published
2008 | Year | 11 | Month | 20 | Day |
2009 | Year | 04 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 06 | Month | 30 | Day |
2014 | Year | 08 | Month | 31 | Day |
http://www.thelancet.com/pdfs/journals/landia/PIIS2213-8587%2814%2970194-9.pdf
2009 | Year | 03 | Month | 27 | Day |
2015 | Year | 07 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002148
Research Plan | |
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Registered date | File name |
2015/07/16 | EVALUATE臨床試験計画書110509kuro血糖.doc |
Research case data specifications | |
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Registered date | File name |
2015/07/16 | 【確定】 解析時データ対応確認内容3_20130626.xls |
Research case data | |
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Registered date | File name |