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Recruitment status Completed
Unique ID issued by UMIN UMIN000005956
Receipt No. R000005773
Scientific Title Investigation of an efficacy of eplerenone combined therapy for hypertensive patients with chronic kidney disease that enough hypotensive effect are not obtained with an angiotensin receptor blocker
Date of disclosure of the study information 2011/07/11
Last modified on 2016/01/10

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Basic information
Public title Investigation of an efficacy of eplerenone combined therapy for hypertensive patients with chronic kidney disease that enough hypotensive effect are not obtained with an angiotensin receptor blocker
Acronym Optimal Hypertension Therapy with Aldosterone Blocker Selara (OWASE)
Scientific Title Investigation of an efficacy of eplerenone combined therapy for hypertensive patients with chronic kidney disease that enough hypotensive effect are not obtained with an angiotensin receptor blocker
Scientific Title:Acronym Optimal Hypertension Therapy with Aldosterone Blocker Selara (OWASE)
Region
Japan

Condition
Condition Hypertensive patients with chronic kidney disease that enough hypotensive effect is not obtained with an angiotensin receptor blocker
Classification by specialty
Medicine in general Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the antialbuminuric effect of eplerenone by comparing the effects of thiazide diuretics on change in urinary albumin/creatinine ratio
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes in urinary albumin/creatinine ratio from pretreatment period to 12 months of treatment
Key secondary outcomes 1. Change in office blood pressure
2. Change in estimated glomerular filtration rate (eGFR)
3. Change in urinary protein
4. Change in brachial-ankle pulse wave velocity (baPWV)
5. Change in BNP
6. Change in cardiac ultrasonography findings (ejection fraction, E', A', E/E', left ventricukar mass)
7. Cerebro-cardio-vascular events (all death, non-fatal myocardial infarction, angina pectoris, stroke, heart failure)
8. Side effect of eplerenone or thiazide diuretics

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Eplerenone (50mg/day) is added in patients under treatment of angiotensin receptor blocker (ARB). If blood pressure dose not reach to lower than 130/80mmHg, other antihypertensive drug except ARB, eplerenone and thiazide diuretics is added.
Interventions/Control_2 Thiazide diuretics (hydrochlorothiazide 12.5mg/day or trichlormetiazide 1mg/day) is added in patients under treatment of angiotensin receptor blocker (ARB). If blood pressure dose not reach to lower than 130/80mmHg, other antihypertensive drug except ARB, eplerenone and thiazide diuretics 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Among the following, the patient satisfying all the conditions from 1 to 4 becomes a subject.
1. Urinary albumin/creatinine ratio is more than 10mg/gCr
2. Though angiotensin receptor blocker has been administered for more than 3 months, systolic blood pressure is equal or more than 130mmHg or diastolic blood pressure is equal or more than 80mmHg (in patients developing that urinary protein is equal or more than 1g/day, systolic blood pressure 125mmHg or diastolic blood pressure is qual or more than 75mmHg)
3. Age is equal or more than 20
4. Patients who have given written informed consent to participate in this study
Key exclusion criteria 1. Uncontrolled hypertension (systolic blood pressure is equal or more 220 mmHg, or diastolic blood pressure is equal or more 110 mmHg)
2. Unstable angina pectoris
3. Myocardial infarction occurs within 6 months
4. Severe heart failure (NYHA class is equal or more than III)
5. Severe arrhythmia (frequent ventricular or atrial extrasystole, prolonged ventricular tachycardia, atrial tachyarrhythmia, atrial fibrillation, atrial flutter, sick sinus syndrome or atrio-ventricular block)
6. eGFR is less than 36mL/min/1.73m2
7. Severe liver dysfunction or Child-Pugh class score is C
8. Active cancer
9. Serum potassium is equal or more than 5 mEq/L
10. Diabetic patients with microalbuminuria (urinary albumin/creatinine ratio is equal or more than 30mg/gCr) or proteinuria
11. Supplementation of K or administration of K-sparing diuretics
12. Administration of itraconazole, ritonavir or nelfinavir
13. Administration of steroid or immunosuppressant
14. Pregnant, possible to be pregnant
15. Patient who is already treated for study drugs
16. Patients with allergy or contraindication to study drugs
17. Patients that it is impossible to get an agreement
18. Patients who are inadequate by determination of physician in charge
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Ito
Organization Mie University Graduate School of Medicine
Division name Department of Cardiology and Nephrology
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-231-5015
Email mitoka@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mashio Nakamura
Organization Mie University Graduate School of Medicine
Division name Department of Cardiology and Nephrology
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-231-5015
Homepage URL
Email mashio@clin.medic.mie-u.ac.jp

Sponsor
Institute OWASE study Project Office
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Pfizer Japan Inc.

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 三重大学医学部附属病院
尾鷲総合病院
桑名東医療センター
四日市社会保険病院
三重県立総合医療センター
鈴鹿中央総合病院
松阪中央総合病院
済生会松阪総合病院
伊勢赤十字病院
村瀬病院
岩崎病院
名張市立病院

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Completed
Date of protocol fixation
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 10 Day
Last modified on
2016 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005773


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