UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007156 |
|---|---|
| Receipt number | R000008429 |
| Scientific Title | Examination about the combination medical treatment of the antihypertensive drug which assumed extraneous blood pressure an index |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2012/01/27 19:44:26 |
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Basic information
Public title
Examination about the combination medical treatment of the antihypertensive drug which assumed extraneous blood pressure an index
Acronym
The combination medical treatment of the antihypertensive drug which assumed extraneous blood pressure an index
Scientific Title
Examination about the combination medical treatment of the antihypertensive drug which assumed extraneous blood pressure an index
Scientific Title:Acronym
The combination medical treatment of the antihypertensive drug which assumed extraneous blood pressure an index
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine efficacy, safety, and a cardiovascular system predictor marker by performing antihypertensive therapy using olmesartan medoxomil and azelnidipine, and tie it to the improvement of the future heart disease therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Achievement rate of antihypertensive therapy which assumed extraneous blood pressure in JSH2009 an index
Key secondary outcomes
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
First we prescribe olmesartan medoxomil for hypertension patient for 12 weeks. We continue the therapy more for 16 weeks when it works well. However, when the efficacy of the drug is not enough, we add the prescription of azelnidipine for 16 weeks.
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
essential hypertension
Key exclusion criteria
secondary hypertension
angina pectoris
severe heart disease
severe diabetic mellitus (HbA1c > 10%)
severe liver disease (AST or ALT > 100U/L)
malignancy
allergy for olmesartan medoxomil or azelnidipine
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Fujino |
Organization
Kanazawa University
Division name
Division of Cardiovascular Medicine
Zip code
Address
Takara-machi 13-1, Kanazawa-City
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kanazawa University
Division name
Division of Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
nfujino@med.m.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 04 | Month | 01 | 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
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
| 2012 | Year | 01 | Month | 27 | Day |
Last modified on
| 2012 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008429
