UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006920 |
|---|---|
| Receipt number | R000007861 |
| Scientific Title | Randomized trial of olmesartan and azelnidipine for treatment of hypertension with chronic kidney disease |
| Date of disclosure of the study information | 2011/12/20 |
| Last modified on | 2016/03/30 09:50:14 |
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Basic information
Public title
Randomized trial of olmesartan and azelnidipine for treatment of hypertension with chronic kidney disease
Acronym
Best Combination Therapy in Juntendo(BECOME-J)
Scientific Title
Randomized trial of olmesartan and azelnidipine for treatment of hypertension with chronic kidney disease
Scientific Title:Acronym
Best Combination Therapy in Juntendo(BECOME-J)
Region
| Japan |
Condition
Condition
hypertension with CKD
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the beneficial effects of olmesartan and azalnidipine on lowering BP and renal protectection in hypertensive patients with CKD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
albuminuria
blood pressure
eGFR
Key secondary outcomes
Urinary angiotensinogen excresion
serum ADMA
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ormesartan 40mg
Interventions/Control_2
Ormesartan 20mg plus Azelnidipine16mg
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
Patients
1) who have treated with ormesartan 20mg alone for more than 1 month
2)whose systolic BP>125mmHg and/or diastolic BP 75mmHg
3) with macro- or micro-albuminuria
Key exclusion criteria
1)secondary hypertension
2)patients who used to have side effects by ormesartan and/or azelnidipine
3)pregnacy
4)with steroid therapy
5)malignancy
6)severe liver disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Horikoshi |
Organization
Juntendo University
Division name
Nephrology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1065
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Horikoshi |
Organization
Juntendo University
Division name
Nephrology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1065
Homepage URL
satoshi@juntendo.ac.jp
Sponsor or person
Institute
Division of Nephrology, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Research Center, Juntendo 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
| 2011 | Year | 12 | Month | 20 | 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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | 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
| 2011 | Year | 12 | Month | 20 | Day |
Last modified on
| 2016 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007861
