UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012538 |
|---|---|
| Receipt number | R000014662 |
| Scientific Title | Effect of high-dose angiotensin II receptor blocker (ARB) monotherapy versus combination therapy of ARB with calcium channel blocker on vascular endothelial function in patients with essential hypertenson |
| Date of disclosure of the study information | 2013/12/10 |
| Last modified on | 2014/06/20 18:24:24 |
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Basic information
Public title
Effect of high-dose angiotensin II receptor blocker (ARB) monotherapy versus combination therapy of ARB with calcium channel blocker on vascular endothelial function in patients with essential hypertenson
Acronym
Effect of high-dose ARB monotherapy versus combination therapy of ARB with CCB on vascular endothelial function in patients with essential hypertenson
Scientific Title
Effect of high-dose angiotensin II receptor blocker (ARB) monotherapy versus combination therapy of ARB with calcium channel blocker on vascular endothelial function in patients with essential hypertenson
Scientific Title:Acronym
Effect of high-dose ARB monotherapy versus combination therapy of ARB with CCB on vascular endothelial function in patients with essential hypertenson
Region
| Japan |
Condition
Condition
essential hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to compare the effects of high-dose angiotensin II receptor blocker (ARB) monotherapy versus combination therapy of ARB with calcium channel blocker on vascular endothelial function in patients with essential hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
vascular endothelial function
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
valsartan 160mg/day
Interventions/Control_2
valsartan 160mg/day+amlodipine 5mg/day
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 not achieve the target blood pressure
Key exclusion criteria
1. History of ischemic heart disease
2. History of cerebrovascular disease
3. patients with renal dysfunction(serum creatinine greater than 1.5mg/dL)
4. patients with diabetes who are poor blood sugar control(HbA1c greater than8.0%)
5. By the change of antihypertensive drugs, blood pressure instability is suspected.
6. patients who takes high-dose ARB
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobukazu Ishizaka |
Organization
Osaka Medical College
Division name
Internal Medicine3
Zip code
Address
Daigaku-machi2-7 Takatsuki-shi Osaka Japan
TEL
072-683-1221
ishizaka@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Sohmiya |
Organization
Osaka Medical College
Division name
Internal Medicine3
Zip code
Address
Daigaku-machi2-7 Takatsuki-shi Osaka Japan
TEL
072-683-1221
Homepage URL
in3025@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 10 | Day |
Last modified on
| 2014 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014662
