UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cardioprotective effect of ARB in old patients with hypertension and coronary artery disease - a multicenter trial -.
Title of the study (Brief title)	Cardioprotection in the elderly by ARB
Region	Japan

Condition
Condition	Elderly patients with hypertension and coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate clinical effects of PPARgamma-activated by irbesartan
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in calcium score of coronary artery and aortic valve from baseline Change in echocardiography from baseline
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Irbesartan
Interventions/Control_2	Valsartan or Candesartan
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	History of coronary artery disease Over 60 years Hypertension and with at least one of risks of Diabetes mellitus Chronic kidney disease Obesity
Key exclusion criteria	Previous ARB-induced Hypersensitivity to ARB Serious impairment of liver function Serious renal dysfunction Hemodialysis treated Pregnant woman or who has possibility
Target sample size	100

Research contact person
Name of lead principal investigator	Satoshi Nakatani
Organization	Osaka University Graduate School of medicine
Division name	Division of Functional Diagnostics, Department of Health Sciences
Address	1-7 Yamada-oka, suita Osaka
TEL	06-6879-2561
Email

Public contact
Name of contact person	Satoshi Nakatani
Organization	Osaka University Graduate School of medicine
Division name	Division of Functional Diagnostics, Department of Health Sciences
Address
TEL	06-6879-2561
Homepage URL
Email

Sponsor
Institute	Association of APPOINT-study
Institute
Department

Funding Source
Organization	Associations for establishment of evidence in interventions
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 02 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 07 Month 11 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2016 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 02 Month 13 Day
Last modified on	2016 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008567