UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012586 |
|---|---|
| Receipt number | R000014722 |
| Scientific Title | AziLsartan treatMent as a swItch strateGy for improvement of uncontrolled Hypertension and blood pressure variabiliTY |
| Date of disclosure of the study information | 2013/12/16 |
| Last modified on | 2015/01/15 09:59:36 |
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Basic information
Public title
AziLsartan treatMent as a swItch strateGy for improvement of uncontrolled Hypertension and blood pressure variabiliTY
Acronym
ALMIGHTY
Scientific Title
AziLsartan treatMent as a swItch strateGy for improvement of uncontrolled Hypertension and blood pressure variabiliTY
Scientific Title:Acronym
ALMIGHTY
Region
| Japan |
Condition
Condition
Essential hyertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of azilsartan as a switch strategy on blood pressure lowering and blood pressure variabiliy in patinets wiht uncontrolled Hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in day-by-day blood pressure vriablity after azilsartan treatment
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
azilsartan
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
| 30 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who do not achieved the target blood pressure according to JSH guideline 2009
Key exclusion criteria
1.Secondary hypertension
2.Grade III hypertension according JSH2009
3.Congestive heart failure
4.Severe valvular heart disease
5.Myocardial infarction and cerebellar infarction within 6 months
6.Chronic atrial filtration
7.Malignant arrhythmia
8.Renal insufficiency (=>serum creatinine 2mg/dl)
9.Severe liver disease
10.Chronic inflammatory disease
11.Malignant disease (life prognosis less than 6 months)
12.Patients receiving other RAS inhibitors
13.Patients who are determined by the investigators to be unsuitable
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-5-1 Shikada-cho Kita-ku Okayama
TEL
086-235-7351
miyoshit@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-5-1 Shikada-cho Kita-ku Okayama
TEL
086-235-7351
Homepage URL
miyoshit@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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
| 2013 | Year | 12 | Month | 16 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | 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
| 2013 | Year | 12 | Month | 16 | Day |
Last modified on
| 2015 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014722
