UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014186 |
|---|---|
| Receipt number | 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 13:52:09 |
* 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
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
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
hoshide@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016521
