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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002925
Receipt No. R000003248
Scientific Title Efficacy of Eplerenone monotherapy and Valsartan monotherapy on patients of Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension.
Date of disclosure of the study information 2009/12/28
Last modified on 2019/07/09

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Basic information
Public title Efficacy of Eplerenone monotherapy and Valsartan monotherapy on patients of Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension.
Acronym A pilot study to compare efficacy of Eplerenone monotherapy with Valsartan monotherapy.
Scientific Title Efficacy of Eplerenone monotherapy and Valsartan monotherapy on patients of Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension.
Scientific Title:Acronym A pilot study to compare efficacy of Eplerenone monotherapy with Valsartan monotherapy.
Region
Japan

Condition
Condition Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension.
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A pilot study to assess the clinical utility of Eplerenone monotherapy on subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension by comparing with standard antihypertensive therapy, Valsartan monotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Lowering rate of urinary 8-OHdG and urinary 8-Isoprostane from baseline after 6 weeks.
Key secondary outcomes Lowering rate of blood pressure and CRP from baseline after 6 weeks.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 50mg of Eplerenone monotherapy once daily for 6 weeks on subclinical Cushing's syndrome
Interventions/Control_2 80mg of Valsartan monotherapy once daily for 6 weeks on subclinical Cushing's syndrome
Interventions/Control_3 50mg of Eplerenone monotherapy once daily for 6 weeks on non-functioning adrenocortical adenoma
Interventions/Control_4 80mg of Valsartan monotherapy once daily for 6 weeks on non-functioning adrenocortical adenoma
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

Not applicable
Gender Male and Female
Key inclusion criteria (a) Patients with hypertension(>=130/80mmHg)
(b)Patients are outpatients or inpatients
Key exclusion criteria (a) Patients with a history of severe cardiovascular or cerebrovascular disease or renal failure.
(b) Patients with aldosterone producing adenoma, Cushing's syndrome and malignant tumor.
(c) Patients who have taken ARB, ACEI, aldosterone antagonist or diuretics therapy.
(d) Patients have contraindication of Eplerenone and Valsartan.
(e) Patients with severe liver damage.
(f) Patients are pregnant or patients breast-feeding, potentially pregnant.
(g) Patients who are diagnosed to be ineligible by the investigator
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiminori Yamane
Organization Hiroshima University Hospital
Division name Department of Endocrinology and Diabetes mellitus
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL 082-257-5196
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tsuguka Shiwa
Organization Hiroshima University Hospital
Division name Department of Endocrinology and Diabetes mellitus
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL 082-257-5196
Homepage URL
Email tsuguka@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Department of Endocrinology and Diabetes mellitus
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 12 Month 28 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 Terminated
Date of protocol fixation
2009 Year 11 Month 30 Day
Date of IRB
2009 Year 12 Month 01 Day
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2019 Year 07 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 21 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003248

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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