UMIN-CTR Clinical Trial

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