UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004581
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email takeday@med.kanazawa-u.ac.jp

Sponsor
Institute Department of Internal Medicine, Graduate School of Medical Science, Kanazawa University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005473

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.