UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003315 |
|---|---|
| Receipt number | R000003668 |
| Scientific Title | Study to compare the effect of benidipine and amlodipine on blood pressure and renal function in patients with type 2 diabetes mellitus and hypertension treated with angiotensin 2 receptor antagonists |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2011/09/13 12:45:41 |
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Basic information
Public title
Study to compare the effect of benidipine and amlodipine on blood pressure and renal function in patients with type 2 diabetes mellitus and hypertension treated with angiotensin 2 receptor antagonists
Acronym
Comparison of benidipine and amlodipide in DM
Scientific Title
Study to compare the effect of benidipine and amlodipine on blood pressure and renal function in patients with type 2 diabetes mellitus and hypertension treated with angiotensin 2 receptor antagonists
Scientific Title:Acronym
Comparison of benidipine and amlodipide in DM
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus with hypertension
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effect on blood pressure and renal function and safety of benidipine and amlodipine for type 2 diabetic patients complicated with hypertension and treated with angiotensin 2 receptor antagonists.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Urinary albumin/creatinine ratio
Key secondary outcomes
1) Blood pressure
2) urinary protein/creatinine, eGFR
3) safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
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
benidipine 4mg
Interventions/Control_2
amlodipine 2.5mg
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) type 2 diabetic patients with hypertension not attaining the goal of JSH2009
2) Urinary albumin/creatinine > or = 30mg/gCr
3) Serum creatinine < or = 2.0mg/dl
Key exclusion criteria
1) Patients with cerebro-cardiovascular disease, such as unstable angina, acute myocardial infarction, and stroke within 6 months
2) Patients with congestive heart failure or severe arrhythmia
3) Patients with severe liver dysfunction
4) Patients with severe renal dysfunction or nephrotic syndrome
5) Pregnant patients
6) Patients allergic to benidipine or amlodipine
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Arai |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Sciences
Zip code
Address
53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3861
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Iehara |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of nephrology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3110
Homepage URL
niehara@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 11 | Day |
Last modified on
| 2011 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003668
