UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000525 |
|---|---|
| Receipt number | R000000636 |
| Scientific Title | Olmesartan-based versus Amlodipine-based Strategies for Circulating Marker Modification in Essential Hypertension Study |
| Date of disclosure of the study information | 2006/11/21 |
| Last modified on | 2008/12/09 09:32:54 |
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Basic information
Public title
Olmesartan-based versus Amlodipine-based Strategies for Circulating Marker Modification in Essential Hypertension Study
Acronym
OASES Study
Scientific Title
Olmesartan-based versus Amlodipine-based Strategies for Circulating Marker Modification in Essential Hypertension Study
Scientific Title:Acronym
OASES Study
Region
| Japan |
Condition
Condition
Essential Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of olmesartan-based with amlodipine-based anti-hypertensive therapies on cardiovascular risk marker levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Cardiovascular risk marker levels
(2) Changes in cardiovascular risk
marker levels
Key secondary outcomes
Major cardiovascular adverse events (cardiac death, non-fatal myocardial infarction, revascularization or hospitalization by angina, hospitalization by heart failure, cerebrovascular events: cerebral infarction, cerebral hemorrhage, subarchnoidal hemorrhage)
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
Olmesartan (max. dose=40 mg/day)-based anti-hypertensive medical therapy
Interventions/Control_2
Amlodipine (max. dose=10 mg/day)-based anti-hypertensive medical therapy
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age 50–79 years.
2. Untreated or uncontrolled patients with essential hypertension (systolic BP=>140 mmHg or diastolic BP=>90 mmHg in a sitting position at clinic).
3. No previous medication of ACE inhibitors or ARB within 3 months.
4. Obtained written informed consent.
Key exclusion criteria
1.Cerebrovascular and cardiovascular events including myocardial infarction, cerebral infarction, cerebral hemorrahge and subarchnoidal hemorrahge within 6 months.
2.PTCA or CABG performed within 6 months.
3.Scheduled PTCA or CABG in the future.
4.Congenital or rheumatic heart disease.
5.Severe arrhythmia.
6.Severe liver insufficiency.
7.Severe renal insufficiency.
8.Active cancer or treatment for cancer within 5 years.
9.Pregnancy, possible pregnancy.
10.Not suitable to the clinical trial as judged by a physician.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kimura |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
54Shogoin-Kawaharacho, Sakyo-ku, Kyoto 606-8397 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Furukawa |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
TEL
075-751-4255
Homepage URL
Sponsor or person
Institute
Department of Cardiovascular Medicine,
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine,
Kyoto University Hospital
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
| 2006 | Year | 11 | Month | 21 | 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
Date of protocol fixation
| 2006 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 11 | Month | 21 | Day |
Last modified on
| 2008 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000636
| 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 |
