UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016704 |
|---|---|
| Receipt number | R000019375 |
| Scientific Title | Efficacy of combination tablet of angiotensin receptor blocker and high dose calcium channel blocker in essential hypertension |
| Date of disclosure of the study information | 2015/03/04 |
| Last modified on | 2017/07/24 16:57:40 |
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Basic information
Public title
Efficacy of combination tablet of angiotensin receptor blocker and high dose calcium channel blocker in essential hypertension
Acronym
Efficacy of combination tablet of ARB and high dose CCB in essential hypertension
Scientific Title
Efficacy of combination tablet of angiotensin receptor blocker and high dose calcium channel blocker in essential hypertension
Scientific Title:Acronym
Efficacy of combination tablet of ARB and high dose CCB in essential hypertension
Region
| Japan |
Condition
Condition
patients with essential hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of combination therapy of regular dose ARB and 5 mg of amlodipine and combination tablet of regular dose ARB and 10 mg of amlodipine in patients with essential hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
blood pressure reduction
Key secondary outcomes
Changes in
- endothelial function(FMD), atherosclerosis (CAVI)
- urinary protein and albumin and eGFR
- uric acid
- plasma renin activity, aldosterone, prorenin, and soluble (pro)renin receptor
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
Combination therapy of regular dose ARB and 5 mg of amlodipine is changed to therapy with combination tablet of regular dose ARB and 10 mg of amlodipine.
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
- patients with essential hypertension
- poor blood pressure control under combination therapy of regular dose ARB and 5 mg of amlodipine
Key exclusion criteria
pregnant women or women who are possibly pregnant
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhiro Ichihara |
Organization
Tokyo Women's Medical University
Division name
Department of Medicine II
Zip code
Address
8-1 Kawada-cyo, Shinjyuku-ku, Tokyo
TEL
03-3353-8111
atzichi@endm.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Morimoto |
Organization
Tokyo Women's Medical University
Division name
Department of Medicine II
Zip code
Address
8-1 Kawada-cyo, Shinjyuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
smorimoto@endm.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
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
東京女子医科大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 04 | Day |
Last modified on
| 2017 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019375
