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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009127
Receipt No. 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

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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
Last 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
Email hadac@med.kurume-u.ac.jp

Public contact
1st 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
Email hadac@med.kurume-u.ac.jp

Sponsor
Institute Departmenet of Internal Medicine Division of Cardio-Vascular Medicine and Department of Community Medicine
Institute
Department

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
Email 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
URL(English) https://upload.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


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