UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002207 |
|---|---|
| Receipt number | R000002713 |
| Scientific Title | Blood pressure lowering effect of combination therapy of angiotensin receptor blocker (ARB) and Ca antagonist in patients with high risk hypertension |
| Date of disclosure of the study information | 2009/07/22 |
| Last modified on | 2009/07/15 21:31:26 |
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Basic information
Public title
Blood pressure lowering effect of combination therapy of angiotensin receptor blocker (ARB) and Ca antagonist in patients with high risk hypertension
Acronym
Therapeutic efficacy of combination therapy of angiotensin receptor blocker (ARB) and Ca antagonist to patients with high risk hypertension
Scientific Title
Blood pressure lowering effect of combination therapy of angiotensin receptor blocker (ARB) and Ca antagonist in patients with high risk hypertension
Scientific Title:Acronym
Therapeutic efficacy of combination therapy of angiotensin receptor blocker (ARB) and Ca antagonist to patients with high risk hypertension
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the blood lowering efficacy between olmesartan medoxomil plus azelnidipine administration and valsartan plus amlodipine besilate administration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Blood lowering effect and percentage of the attainment of therapeutic goal three and six months after treatment
Key secondary outcomes
Chenges of various biomarker six months after treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
Combination of olmesartan medoxomil 20mg/day and azelnidipine 16mg/day
Interventions/Control_2
Combination of valsartan 80mg/day and amlodipine besilate 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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients categolized into
high risk group
Key exclusion criteria
1. Patients with hypersensitive history to olmesartan medoxomil, azelnidipine, valsartan and amlodipine besilate
2. Pregnant women or women who have possibility of pregnancy
3. Patients administrated with azole antifungal drug or protease inhibitor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Sata |
Organization
Institute of Health Biosciences, The University of Tokushima Graduate School
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7851
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Iwase |
Organization
Institute of Health Biosciences, The University of Tokushima Graduate School
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7851
Homepage URL
tiwase@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Institute of Health Biosciences, The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Institute of Health Biosciences, The University of Tokushima Graduate School
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
| 2009 | Year | 07 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 15 | Day |
Last modified on
| 2009 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002713
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
