UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010768
Receipt No. R000012590
Scientific Title High-dose angiotensin II receptor blocker (ARB), olmesartan, monotherapy versus combination therapy of normal-dose olmesartan with selective aldosterone antagonist, selara, treatment on central blood pressure in patients with ischemic heart disease: a single-center, prospective, randomized, open-labes study
Date of disclosure of the study information 2013/05/29
Last modified on 2015/12/25

* 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 High-dose angiotensin II receptor blocker (ARB), olmesartan, monotherapy versus combination therapy of normal-dose olmesartan with selective aldosterone antagonist, selara, treatment on central blood pressure in patients with ischemic heart disease: a single-center, prospective, randomized, open-labes study
Acronym High-dose angiotensin II receptor blocker (ARB), olmesartan, monotherapy versus combination therapy of normal-dose olmesartan with selective aldosterone antagonist, selara, treatment on central blood pressure in patients with ischemic heart disease
Scientific Title High-dose angiotensin II receptor blocker (ARB), olmesartan, monotherapy versus combination therapy of normal-dose olmesartan with selective aldosterone antagonist, selara, treatment on central blood pressure in patients with ischemic heart disease: a single-center, prospective, randomized, open-labes study
Scientific Title:Acronym High-dose angiotensin II receptor blocker (ARB), olmesartan, monotherapy versus combination therapy of normal-dose olmesartan with selective aldosterone antagonist, selara, treatment on central blood pressure in patients with ischemic heart disease
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Hypertension is an important risk factor for cardiovascular disease.
Our purpose is to compare the effect of High-dose angiotensin II receptor blocker (ARB) monotherapy versus combination therapy of normal-dose ARB with selective aldosterone antagonist treatment on central blodd pressure, left ventricular mass index (LVMI), and plasma aldosterone concentration (PAC) in hypertensive patients with ischemic heart disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Central blood pressure
-Left ventricular mass index (LVMI)
-Plasma aldosterone concentration (PAC)
Key secondary outcomes -Casual blood pressure (SBP and DBP)
-Plasma renin activity
-LVEDP
-Left atrial dimension, E/A, and E/E' ration seen by echo-cardiographic measurement
-Urine albumin
-Pulse Wave Velocity
-ECG

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 -Olmesartan 40mg
-Once daily
-Treatment period: 8 months
Interventions/Control_2 -Olmesartan 20mg and Eplerenone 50mg
-Once daily
-Treatment period: 8 months
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) ischemic heart disease patients
2) clinic SBP >=130 mmHg and/or DBP >=80 mmHg
3) ability of oral administration
4) male or female subjects over 20 years of age and under 85 years of age at the time of informed consent
5) eGFR >= 50 ml/min/1.73m2
6) serum potassium < 5.0 mEq/L
7) ability to provide written informed consent
Key exclusion criteria 1) myocardial infarction
2) subjects who already have Olmesartan or Eplerenone at the entry
3) history of allergy against these drugs or similar compounds
4) subjects whose serum potassium level is over 5.0mEq/L
5) Diabetes mellitus patients whose albumin excretion rates > 300mg/24hours
6) subjects with moderate renal dysfunction (eGFR <50 ml/min/1.73m2)
7) hepatic dysfunction (Child-Pugh C)
8) subjects taking potassium supplements, potassium saving diuretics, or strong CYP3A4-inhibitors (Itraconazol, Ritonavir, and Nelfinavir)
9) Pregnancy
10) Additionally, patient who judged that doctor in charge is improper (For example, FH or secondary hyperlipidemia, tumor, administering cyclosporine, drug abuse or alcoholism, hypothyroidism and inherited stripe disease or the family medical histories, previous history of medicinal muscle disorder.)
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Myong Hwa Yamamoto
Organization Showa University Northern Yokohama Hospital.
Division name Division of cardiology and cardiac catheterization laboratory
Zip code
Address 35-1 Chigasakichuo Tsuzuki-ku Yokohama Kanagawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Showa University Northern Yokohama Hospital
Division name Division of cardiology and cardiac catheterization laboratory
Zip code
Address 35-1 Chigasakichuo Tsuzuki-ku Yokohama Kanagawa
TEL
Homepage URL
Email

Sponsor
Institute Showa University Northern Yokohama Hospital.
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

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 29 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 Terminated
Date of protocol fixation
2013 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 29 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 20 Day
Last modified on
2015 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012590

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.