UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010610 |
|---|---|
| Receipt number | R000012405 |
| Scientific Title | Medical effects of Azilsartan in patients with hypertension not controlled by other ARBs |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2020/12/23 21:45:03 |
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Basic information
Public title
Medical effects of Azilsartan in patients with hypertension not controlled by other ARBs
Acronym
MAZIC study
Scientific Title
Medical effects of Azilsartan in patients with hypertension not controlled by other ARBs
Scientific Title:Acronym
MAZIC study
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of Azilsartan in patients with hypertension not achieve the target blood pressure of JSH2009 by other ARBs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
hospital blood pressure
Key secondary outcomes
home BP(early morning, evening),ABPM,
urine albumin, BNP, hs-CRP, urinary sodium excretion, Serum K, eGFR, HbA1c
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients not achieve the target blood pressure of JSH2009 with other ARBs
Key exclusion criteria
1) A history of allergy/hypersensitivity
2) Pregnant women
12) Not eligible for this study based on the decision's of a physician
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Watarai |
Organization
Anjo Kosei Hospital
Division name
department of cardiology
Zip code
Address
28,Higashihirokute,Anjo-cho,Anjo-shi,Aichi-ken
TEL
0566-75-2111
watarai@kosei.anjo.aichi.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenshi Hirayama |
Organization
Anjo Kosei Hospital
Division name
department of cardiology
Zip code
Address
28,Higashihirokute,Anjo-cho,Anjo-shi,Aichi-ken
TEL
0566-75-2111
Homepage URL
kenshi28sep@gmail.com
Sponsor or person
Institute
Nishi Mikawa Cardiologist Conference
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2013 | Year | 05 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 29 | Day |
Last modified on
| 2020 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012405
