UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Blood pressure lowering effect of one compound tablet replacement as two tablets of angiotensin 2 receptor blocker(ARB) and calcium channel blocker(CCB)
Title of the study (Brief title)	ECO Tablet trial
Region	Japan

Condition
Condition	the hypertensive patient who has taken ARB and CCB
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate tne blood pressure lowering effect of one compound tablet replacement as two tablets of angiotensin 2 receptor blocker(ARB) and calcium channel blocker(CCB).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	change of systolic blood pressure at a medical office
Key secondary outcomes	change of diastololic blood pressure at a medical office, blood presssure at home, compliance of drug

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	To the hypertensive patient who has taken azelnidipine 16mg/day and olmesartan 20mg/day, or amlodipine 5mg/day and olmesartan 20mg/day, respectively, more than one month (4 weeks), we replace one compound drug(Rezaltas HD) that ingredient is azelnidipine 16mg and olmesartan 20mg.
Interventions/Control_2
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	a) the hypertensive patient who has taken azelnidipine 16mg/day and olmesartan 20mg/day, or amlodipine 5mg/day and olmesartan 20mg/day, respectively, more than one month (4 weeks). b)the patient whose blood pressure at a mediacl office is below 159/99mmHg. c)the patinet above 20 years-old.
Key exclusion criteria	a) patient with previous allergic reaction to azelnidipine or olmesartan. b) female patient who has possibility of pregnancy. c) patient treated with azole antifungal drug or HIV protease inhibitor. d) patient who has taken hemodialysis or has severe renal dysfunction (serume creatine level is above 2.0mg/dL). e) patient considered to be improper to this study by attending doctor.
Target sample size	200

Research contact person
Name of lead principal investigator	Hiroshi Ito
Organization	Okayama Univesity Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Cardiovascular Medicine
Address	2-5-1, Shikata-cho, Kita-ku, Okayama
TEL	086-235-7349
Email	itomd@md.okayama-u.ac.jp

Public contact
Name of contact person	Kunihisa Kohno
Organization	Okayama Univesity Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Cardiovascular Medicine
Address	2-5-1, Shikata-cho, Kita-ku, Okayama
TEL	086-235-7351
Homepage URL
Email	kunihisakohno@msn.com

Sponsor
Institute	Department of Cardiovascular Medicine, Okayama Univesity Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	The adult cardiovascular reserch foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

あしもりクリニック（岡山県）、井上クリニック（兵庫県）、井原市民病院（岡山県）、庵谷医院（岡山県）、井村医院（岡山県）、氏平医院（岡山県）、岡山医療センター（岡山県）、岡山光南病院（岡山県）、岡山済生会総合病院（岡山県）、岡山市立市民病院（岡山県）、岡山赤十字病院（岡山県）、岡山大学病院（岡山県）、岡山ハートクリニック（岡山県）、香川県立中央病院（香川県）、香川成人医学研究所附属診療所（香川県）、香川労災病院（香川県）、笠岡市立市民病院（岡山県）、笠岡第一病院（岡山県）、かじやま内科循環器科（広島県）、鴨方クリニック（岡山県）、草加病院（岡山県）、康愛クリニック（岡山県）、河野医院（広島県）、小林内科診療所（岡山）、心臓病センター榊原病院（岡山県）、杉江医院（岡山県）、住友別子病院（愛媛県）、高松大林病院（香川県）、高松赤十字病院（香川県）、時末消化器科内科医院（岡山県）、なかやまクリニック（岡山県）、難波医院（岡山県）、長谷川紀念病院（岡山県）、はせ川内科循環器科医院（香川県）、姫路赤十字病院（兵庫県）、広島逓信病院（広島県）、福嶋医院（岡山県）、福山医療センター（広島県）、福山市民病院（広島県）、ふよう内科クリニック（岡山県）、松原クリニック循環器科内科（山口県）、松山市民病院（愛媛県）、南坊井上内科循環器科医院（広島県）、山下産婦人科内科医院（広島県）、山中医院（岡山県）、山成医院（岡山県）

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 23 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2015 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2012 Year 07 Month 05 Day
Last modified on	2017 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009830