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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003323
Receipt No. R000004036
Scientific Title Comparative study on the effects of calcium antagonists on central blood pressure
Date of disclosure of the study information 2010/04/01
Last modified on 2012/03/22

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Basic information
Public title Comparative study on the effects of calcium antagonists on central blood pressure
Acronym Azeldinipine study
Scientific Title Comparative study on the effects of calcium antagonists on central blood pressure
Scientific Title:Acronym Azeldinipine study
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate that the effect of azeldinipine on central blood pressure is similar to that of amlodipine.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AI,urinary protein,eGFR
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 azeldinipine
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Among the patients with CKD, the subjucts of this test would be those with high blood pressure despite of antihypertensive treatent. Envelop method was used to devide into 2 groups. One group should take amlodipine, and the other group do azeldinipine.
Key exclusion criteria Exclusion criteria would be uncontrolable
hypertension, sustained hypotension, rapid increase in serum creatinine, the start of renal replacement therapy.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuneo Takenaka
Organization Saitama Medical University
Division name Department of Nephrology
Zip code
Address 38 Moro-hongo Moroyama Iruma Saitama Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Saitama Medical University
Division name Department of Nephrology
Zip code
Address 38 Moro-hongo Moroyama Iruma Saitama Japan
TEL
Homepage URL
Email

Sponsor
Institute Saitama Medical Univeristy
Institute
Department

Funding Source
Organization Saitama Medical Univeristy
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
2010 Year 04 Month 01 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
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
2011 Year 06 Month 01 Day
Date analysis concluded
2011 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 12 Day
Last modified on
2012 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004036

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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