UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006605 |
|---|---|
| Receipt number | R000007813 |
| Scientific Title | Randomized study to compare olmesartan + azelnidipine versus valsartan + amlodipine to maximize blood pressure control and organ protection |
| Date of disclosure of the study information | 2011/10/24 |
| Last modified on | 2014/10/24 12:57:08 |
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Basic information
Public title
Randomized study to compare olmesartan + azelnidipine versus valsartan + amlodipine to maximize blood pressure control and organ protection
Acronym
The combination of olmesartan and azelnidipine in high-risk hypertensive patients
Scientific Title
Randomized study to compare olmesartan + azelnidipine versus valsartan + amlodipine to maximize blood pressure control and organ protection
Scientific Title:Acronym
The combination of olmesartan and azelnidipine in high-risk hypertensive patients
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of blood pressure control and organ protection between olmesartan/azelnidipine and valsartan/amlodipine combination therapy in hypertensive patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of clinic and home blood pressure control
Key secondary outcomes
CAVI(Cardio-Ankle Vascular Index)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
olmesartan + azelnidipine
Interventions/Control_2
valsartan + amlodipine
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
Essential hypertensive patients without receiving ARB administration and baseline BP is over 140/90 mmHg at least two BP measurements within 8 weeks.
Key exclusion criteria
Patients were excluded from the study if there was any evidence of secondary hypertension, renal failure (serum creatinine≥2.0mg/dl), severe liver dysfunction, symptomatic heart failure, and past history of cerebral infarction.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Matsubara Hiroaki |
Organization
Kyoto Prefectural University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL
075-251-5511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamada Hiroyuki |
Organization
Kyoto Prefectural University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL
075-251-5511
Homepage URL
hiyamada@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University School of Medicine
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
| 2011 | Year | 10 | Month | 24 | 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
| 2011 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
| 2011 | Year | 10 | Month | 24 | Day |
Last modified on
| 2014 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007813
