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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007156
Receipt No. 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

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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
Email

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
Email nfujino@med.m.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008429

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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