UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016249 |
|---|---|
| Receipt number | R000018857 |
| Scientific Title | Comparison of efficacy and safety of azilsartan and olmesartan in patients with essential hypertension |
| Date of disclosure of the study information | 2015/01/17 |
| Last modified on | 2016/03/24 11:51:42 |
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Basic information
Public title
Comparison of efficacy and safety of azilsartan and olmesartan in patients with essential hypertension
Acronym
CANZONE study
Scientific Title
Comparison of efficacy and safety of azilsartan and olmesartan in patients with essential hypertension
Scientific Title:Acronym
CANZONE study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is still controversial which kinds of angiotensin II type 1 receptor blockers (ARBs) are most useful. We compare the efficacies and safety of two kinds of ARBs (azilsartan vs. olmesartan) in patients with essential hypertension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Depressor effects (office blood pressure)
Key secondary outcomes
1.Anti-inflammatory effects
2. Changes in biochemical parameters in blood and urine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Azilsartan
Interventions/Control_2
Olmesartan
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
1.Patients with essential hypertension who receive ARBs expect for azilsartan and olmesartan
2.Age is 20 years old or more.
3.Patients who give their informed consent to participate for the present study
Key exclusion criteria
1.Severe liver dysfunction.
2.Severe renal dysfunction.
3.Pregnancy or lactation in women.
4.Patients with a history of allergy to any component of the study medications.
5.Patients corresponding to the contraindication of study medications.
6.Ineligible patients according to the judgment by physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keijiro Saku |
Organization
Fukuoka University School of Medicine
Division name
Department of Cardiology
Zip code
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL
81-92-801-1011
saku-k@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-ichiro Miura |
Organization
Fukuoka University School of Medicine
Division name
Department of Cardiology
Zip code
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL
81-92-801-1011
Homepage URL
miuras@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Fukuoka University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology, Fukuoka University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
福岡大学病院、井上病院、藤沢内科、松永病院、城谷病院、出水総合医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 17 | 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
| 2012 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 17 | Day |
Last modified on
| 2016 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018857
