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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014186
Receipt No. R000016521
Scientific Title The effect of a mineralocorticoid receptor antagonist eplerenone on morning home BP in drug-resistant hypertension
Date of disclosure of the study information 2014/06/20
Last modified on 2014/06/06

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Basic information
Public title The effect of a mineralocorticoid receptor antagonist eplerenone on morning home BP in drug-resistant hypertension
Acronym Eplerenone study
Scientific Title The effect of a mineralocorticoid receptor antagonist eplerenone on morning home BP in drug-resistant hypertension
Scientific Title:Acronym Eplerenone study
Region
Japan

Condition
Condition drug-resistant morning hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim this study to clarify the hypothesis that an add-on use of eplerenone or the change to eplerenone from renin-angiotensin inhibitors could lower morning hypertension in patients with drug-resistant hypertension who were already treated with at least 3 antihypertensive drugs including CCB, RAS inhibitors, and diuretics.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Antihypertensive effects of home blood pressure between group I and II in the interventional period 1, and group III and IV in the interventional period 2 will be compared.
Key secondary outcomes

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
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 CCB, RAS inhibitors, and diuretics
Interventions/Control_2 CCB, RAS inhibitors, diuretics and eplerenone
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

Not applicable
Gender Male and Female
Key inclusion criteria (1)Patients with drug-resistant hypertension who were treated by at least 3 antihypertensive drugs (CCB, RAS inhibitors, and diuretics) more than 3 months.

(2)Despite above treatment plus non-pharmacological treatments (Diet and exercise), home morning was > or = 135/85mmHg (either).
Key exclusion criteria 1.Diabetes with albuminuria or proteinuria
2.Allergy, or allergic reaction to study drugs
3. Patients with Hyperkalemia or serum potassium level>5.0mEq/
4.Renal dysfunction (Ccr<50ml/min)
5.Sevre Hepatic damage
6.Taking potassium, or spironolactone
7.Taking Itraconazole, Ritonavir, and Nelfinavir
8. age<20yrs, or dementia
9. Not appropriate for the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL 0285-58-7538
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Hoshide
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL 0285-58-7344
Homepage URL
Email hoshide@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization Jichi Medical University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Washiya Hospital; Koga Red Cross Hospital;
Shobara city National Health Insurance Clinic;Shimonoseki city Tsunoshima Clinic
Tamaki clinic (Miyazaki)
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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 20 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 Completed
Date of protocol fixation
2009 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 06 Day
Last modified on
2014 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016521

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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