UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001714 |
|---|---|
| Receipt number | R000002064 |
| Scientific Title | Effect of imidapril or amlodipine on the progression of diabetic nephropathy in Japanese with type 2 diabetes mellitus: a randomized controlled study |
| Date of disclosure of the study information | 2009/02/17 |
| Last modified on | 2009/02/17 17:58:19 |
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Basic information
Public title
Effect of imidapril or amlodipine on the progression of diabetic nephropathy in Japanese with type 2 diabetes mellitus: a randomized controlled study
Acronym
Effect of imidapril on the progression of diabetic nephropathy with type 2 DM
Scientific Title
Effect of imidapril or amlodipine on the progression of diabetic nephropathy in Japanese with type 2 diabetes mellitus: a randomized controlled study
Scientific Title:Acronym
Effect of imidapril on the progression of diabetic nephropathy with type 2 DM
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus with hypertension
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify and confirm the effect of ACE-1 in Type 2 daibetes with hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
urinary albumin excretion of imidapril
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
imidapril
Interventions/Control_2
amlodipine
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
outpatient
BP>130/85(no medication)
Cre<2.5 mg/dl
Key exclusion criteria
renal stenosis and high renin activity
modelate liver injury
blood control poor
pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinari takamura |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Disease Control and Homeostasis
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2233
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinari takamura |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Disease Control and Homeostasis
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science Department of Disease Control and Homeostasis
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Graduate School of Medical Science Department of Disease Control and Homeostasis
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
| 2009 | Year | 02 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2001 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2002 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 17 | Day |
Last modified on
| 2009 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002064
