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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000002925 |
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Date of registration:
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28/12/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Eplerenone monotherapy and Valsartan monotherapy on patients of Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension.
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Scientific title:
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Efficacy of Eplerenone monotherapy and Valsartan monotherapy on patients of Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension. - A pilot study to compare efficacy of Eplerenone monotherapy with Valsartan monotherapy. |
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Date of first enrolment:
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2009/12/01 |
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Target sample size:
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80 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003248 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kiminori Yamane |
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Address:
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1-2-3, Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
Japan |
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Telephone:
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082-257-5196 |
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Email:
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Affiliation:
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Hiroshima University Hospital Department of Endocrinology and Diabetes mellitus |
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Name:
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Tsuguka Shiwa |
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Address:
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1-2-3, Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
Japan |
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Telephone:
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082-257-5196 |
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Email:
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tsuguka@hiroshima-u.ac.jp |
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Affiliation:
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Hiroshima University Hospital Department of Endocrinology and Diabetes mellitus |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension.
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Intervention(s)
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50mg of Eplerenone monotherapy once daily for 6 weeks on subclinical Cushing's syndrome
80mg of Valsartan monotherapy once daily for 6 weeks on subclinical Cushing's syndrome
50mg of Eplerenone monotherapy once daily for 6 weeks on non-functioning adrenocortical adenoma
80mg of Valsartan monotherapy once daily for 6 weeks on non-functioning adrenocortical adenoma
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Primary Outcome(s)
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Lowering rate of urinary 8-OHdG and urinary 8-Isoprostane from baseline after 6 weeks.
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Secondary Outcome(s)
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Lowering rate of blood pressure and CRP from baseline after 6 weeks.
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date: 01/12/2009
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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09/07/2019 |
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URL:
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