UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009127 |
|---|---|
| Receipt number | R000010687 |
| Scientific Title | Effects of eplerenone on glucose metabolism and blood pressure in hypertensive patients with obesity |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2019/04/25 13:45:32 |
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Basic information
Public title
Effects of eplerenone on glucose metabolism and blood pressure in hypertensive patients with obesity
Acronym
Kurume Eplerenone Study
Scientific Title
Effects of eplerenone on glucose metabolism and blood pressure in hypertensive patients with obesity
Scientific Title:Acronym
Kurume Eplerenone Study
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess effects of aldosterone antagonist, Eplerenone, versus thiazide diuretic on biomarkers of glucose metabolism and blood pressure over 6 months in Japanese obese patients who are currently on antihypertensive(s).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Change from baseline in office SBP/DBP after 24 weeks
Change from baseline in insulin sensitivity (homeostasis model assessment insulin resistance (HOMA-IR)) after 24 weeks
Change from baseline in HbA1c after 24 weeks
Key secondary outcomes
Changes from baseline in hsCRP, eGFR, and adiponectin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eplerenone (Trade name: Selara, Pfizer Inc.)50mg once a day
Interventions/Control_2
Trichlormethiazide (Trade name: Fluitran, Shionogi & Co., Ltd.)1mg once a day
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.Out Patients
2.Patients who are with BMI >=25kg/m2 and SBP>=140mmHg and/or DBP>= 90mmHg at consalting room
Key exclusion criteria
1.Patients on eplerenone or spironolactone during 3 months prior to enrollment
2.Patients on diuretics including trichlormethiazide or combination drugs during 3 months prior to enrollment
3. Patients who experienced myocardial infarction or stroke during 30 days prior to enrollment
4.Patients who had cardiac surgery or PCI during 30 days prior to enrollment
5. Patients with serum potassium >= 5.0 mEq/L
6.Patients with severe liver dysfunction
7.Patients with severe renal dysfunction
8.Patients with grade III hypertension (SBP >=180mmHg and/or DBP >=110mmHg)
9.Patients diagnosed as having secondary hypertension
10.Patients with hypersensitivity with eplerenone or sulfonamide derivative
11.Patients who are contraindicated for use of eplerenone or trichlormethiazide
12.Patients who are on medications contraindicated for use with eplerenone or trichlormethiazide
13.Women who are either pregnant, lactating or of childbearing potential
14.Patients who are considered not appropriate to enroll into this trial under the judgment of the investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Adachi |
Organization
Kurume University School of Medicine
Division name
Departmenet of Internal Medicine Division of Cardio-Vascular Medicine and Department of Community Medicine
Zip code
830-0011
Address
67 Asahi-machi,Kurume,Fukuoka 830-0011
TEL
+81-942-31-7586
hadac@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Adachi |
Organization
Kurume University School of Medicine
Division name
Departmenet of Internal Medicine Division of Cardio-Vascular Medicine and Department of Community Me
Zip code
830-0011
Address
67 Asahi-machi,Kurume,Fukuoka 830-0011
TEL
+81-942-31-7586
Homepage URL
hadac@med.kurume-u.ac.jp
Sponsor or person
Institute
Departmenet of Internal Medicine Division of Cardio-Vascular Medicine and Department of Community Medicine
Institute
Department
Personal name
Funding Source
Organization
Pfizer Japan Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
the ethical committee for theclinical researchi of kurume university
Address
67 asahi-machi,
Tel
+81-942-35-3311
kensui@kurume-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
12138
Org. issuing International ID_1
The Ethical Committee for the Clinical Research of Kurume University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
久留米大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
please see original paper
Publication of results
Published
Result
URL related to results and publications
please see original paper
Number of participants that the trial has enrolled
200
Results
please see original paper
Results date posted
| 2019 | Year | 04 | Month | 25 | Day |
Results Delayed
Results Delay Reason
please see original paper
Date of the first journal publication of results
Baseline Characteristics
please see original paper
Participant flow
please see original paper
Adverse events
please see original paper
Outcome measures
please see original paper
Plan to share IPD
please see original paper
IPD sharing Plan description
please see original paper
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 16 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010687
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/04/25 | KES Medicine.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/04/25 | KES Medicine.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/04/25 | KES Medicine.pdf |
