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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001803
Receipt No. 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

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Basic information
Public title Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial
Acronym Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial (EVALUATE)
Scientific Title Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial
Scientific Title:Acronym Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial (EVALUATE)
Region
Japan

Condition
Condition Hypertensive patients with albuminuria under the treatment of the inhibitor of the renin-angiotension system (RAS)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 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
Key secondary outcomes 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)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 340

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiro Fujita
Organization University of Tokyo Graduate School of Medicine
Division name Department of Nephrology and Endocrinology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8165, Japan
TEL 03-5800-9735
Email toshiro.fujita@rcast.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Ando
Organization University of Tokyo Graduate School of Medicine
Division name Department of Nephrology and Endocrinology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8165, Japan
TEL 03-5800-9119
Homepage URL https://center.umin.ac.jp/islet/evaluate/
Email katsua-tky@umin.sc.jp

Sponsor
Institute EVALUATE Project office
Institute
Department

Funding Source
Organization Pfizer Japan Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 27 Day

Related information
URL releasing protocol http://evaluate.umin.jp/
Publication of results Published

Result
URL related to results and publications http://www.u-tokyo.ac.jp/public/public01_261028_j.html
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2008 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2013 Year 06 Month 30 Day
Date analysis concluded
2014 Year 08 Month 31 Day

Other
Other related information http://www.thelancet.com/pdfs/journals/landia/PIIS2213-8587%2814%2970194-9.pdf

Management information
Registered date
2009 Year 03 Month 27 Day
Last modified on
2015 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002148

Research Plan
Registered date File name
2015/07/16 EVALUATE臨床試験計画書110509kuro血糖.doc

Research case data specifications
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
Registered date File name


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