UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002925 |
|---|---|
| Receipt number | 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 12:48:30 |
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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
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
tsuguka@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Department of Endocrinology and Diabetes mellitus
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003248
