UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004581 |
|---|---|
| Receipt number | R000005473 |
| Scientific Title | Effects of eplerenone on cardiovascular and metabolic disorders in patients with primary aldosteronism |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2010/11/18 10:49:13 |
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Basic information
Public title
Effects of eplerenone on cardiovascular and metabolic disorders in patients with primary aldosteronism
Acronym
Effects of aldosterone blockade in patients with primary aldosteronism
Scientific Title
Effects of eplerenone on cardiovascular and metabolic disorders in patients with primary aldosteronism
Scientific Title:Acronym
Effects of aldosterone blockade in patients with primary aldosteronism
Region
| Japan |
Condition
Condition
essential hypertension, primary aldosteronism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effect on blood pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
blood pressure
Key secondary outcomes
cardiovascular and renal injuries, metaboloc disorders
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eplerenone 50-100mg/d (12-month administration)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Essential hypertension and primary aldosteronism diagnosed by the JSH2009 Guideline
Key exclusion criteria
1. pregnant or lactating women
2. malignant hyperension
3. secondary hypertension except for primary aldosteronism
4. diabetes mellitus patients with unstable glycemic control whose HbA1c is more than 8%, or complicated with diabetic nephropathy more than stage 2.
5. patients whose serum triglycemide is more than 400mg/dL
6. patient who is intolerate or allergic agiansts eplerenone and amlogipine
7. patient whose renal function (estimated GFR) is less than 50mL/min.
8. patient whose serum potassium level is more than 5.0mEq/L
9. patinet who sufferd from severe hepatic injury
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyu Takeda |
Organization
Kanazawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2252
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyu Takeda |
Organization
Kanazawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2252
Homepage URL
takeday@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Graduate School of Medical Science, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
金沢大学附属病院(石川県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 18 | Day |
Last modified on
| 2010 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005473
