UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008360 |
|---|---|
| Receipt number | R000009830 |
| 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) |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2017/06/27 13:36:24 |
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Basic information
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
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
| 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
itomd@md.okayama-u.ac.jp
Public contact
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
kunihisakohno@msn.com
Sponsor or person
Institute
Department of Cardiovascular Medicine, Okayama Univesity Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009830
