UMIN-CTR Clinical Trial

Public title

Blood pressure lowering effect of one compound tablet replacement as two tablets of angiotensin 2 receptor blocker(ARB) and calcium channel blocker(CCB)

Acronym

ECO Tablet trial

Scientific Title

Blood pressure lowering effect of one compound tablet replacement as two tablets of angiotensin 2 receptor blocker(ARB) and calcium channel blocker(CCB)

Scientific Title:Acronym

ECO Tablet trial

Region

Japan

Condition

the hypertensive patient who has taken ARB and CCB

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Ito

Organization

Okayama Univesity Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Cardiovascular Medicine

Zip code

Address

2-5-1, Shikata-cho, Kita-ku, Okayama

TEL

086-235-7349

Email

itomd@md.okayama-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kunihisa Kohno

Organization

Okayama Univesity Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Cardiovascular Medicine

Zip code

Address

2-5-1, Shikata-cho, Kita-ku, Okayama

TEL

086-235-7351

Homepage URL

Email

kunihisakohno@msn.com

Institute

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

Institute

Department

Personal name

Organization

The adult cardiovascular reserch foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2012

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

05

Month

23

Day

Date of IRB

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

Other related information

Registered date

2012

Year

07

Month

05

Day

Last modified on

2017

Year

06

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009830