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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007201
Receipt No. R000008427
Scientific Title Comparison of effects of cilnidipine and azelnidipine on blood pressure and urinary albumin excretion in type 2 diabetics with hypertension
Date of disclosure of the study information 2012/02/02
Last modified on 2012/02/02

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Basic information
Public title Comparison of effects of cilnidipine and azelnidipine on blood pressure and urinary albumin excretion in type 2 diabetics with hypertension
Acronym Comparison of cilnidipine and azelnidipine
Scientific Title Comparison of effects of cilnidipine and azelnidipine on blood pressure and urinary albumin excretion in type 2 diabetics with hypertension
Scientific Title:Acronym Comparison of cilnidipine and azelnidipine
Region
Japan

Condition
Condition Type 2 diabetic patients
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of effects of cilnidipine and azelnidipine on blood pressure and urinary albumin excretion in type 2 diabetics
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes albuminuria
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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 cilnidipine
Interventions/Control_2 azelnidipine
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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria type 2 diabetic patients with hypertension
Key exclusion criteria Patients with severe renal or hepatic disease, overt cardiovascular disease, and malignancy were excluded
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tomoya Mita
Organization Juntendo University Graduate School of Medicine
Division name Metabolism and Endocrinology
Zip code
Address 2-1-1 Hongo Bunkyoku
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Juntendo University Graduate School of Medicine
Division name Metabolism and Endocrinology
Zip code
Address
TEL 03-3813-3111
Homepage URL
Email

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization Juntendo University Graduate School of Medicine
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
2012 Year 02 Month 02 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
2007 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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
2012 Year 02 Month 02 Day
Last modified on
2012 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008427

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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