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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001714
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kanazawa University Graduate School of Medical Science Department of Disease Control and Homeostasis
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002064

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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