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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003956
Receipt No. R000004744
Scientific Title Johoku-Cilnidipine trial of renal function and blood pressure for clinical evaluation.
Date of disclosure of the study information 2010/08/05
Last modified on 2014/08/22

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Basic information
Public title Johoku-Cilnidipine trial of renal function and blood pressure for clinical evaluation.
Acronym Johoku-Cilnidipine trial of renal function and blood pressure for clinical evaluation.(J-CIRCLE)
Scientific Title Johoku-Cilnidipine trial of renal function and blood pressure for clinical evaluation.
Scientific Title:Acronym Johoku-Cilnidipine trial of renal function and blood pressure for clinical evaluation.(J-CIRCLE)
Region
Japan

Condition
Condition Essential Hypertension
Classification by specialty
Medicine in general Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect of Cilnidipine on the blood pressure and renal function.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Office blood pressure
2.Home blood pressure
3.Urinary albumin excretion
Key secondary outcomes 1.Heart rate
2.Serum uric acid
3.Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of Cilnidipine
Interventions/Control_2
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 Administration of amlodipine more than three months,and urinary albumin qualitative is positivity(1+ and above) of hypertensive patients.
Key exclusion criteria Following patients will be excluded from this study.
1.Pregnant women or suspected of being pregnant.
2.Severe liver dysfunction.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Uchida shunya
Organization Teikyo University School of Medicine
Division name Internal medicine
Zip code
Address 2-11-1,kaga,Itabashi-ku,Tokyo
TEL 03-3964-1211
Email s_uchida@netjoy.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Uchida shunya
Organization Teikyo University School of Medicine
Division name Internal medicine
Zip code
Address 2-11-1,kaga,Itabashi-ku,Tokyo
TEL 03-4964-1211
Homepage URL
Email s_uchida@netjoy.ne.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Teikyo University
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 08 Month 05 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
This study assessed the urinary albumin/creatinine ratio and uric acid metabolism in 70 hypertensive patients with CKD in whom the urinary albumin/creatinine ratio had remained  30 mg/g under the treatment of L-type calcium channel blocker amlodipine. Three months after switching to N/L-type calcium channel blocker cilnidipine, blood pressure did not change. However, urinary albumin/creatinine ratio significantly decreased by cilnidipine. Serum uric acid levels showed no significant change. In cases where uric acid production had been high (urinary uric acid/creatinine ratio  0.5), the urinary uric acid/creatinine ratio decreased significantly after cilnidipine treatment, suggesting that cilnidipine can suppress excessive uric acid formation. These results suggest that switching from amlodipine to cilnidipine resulted in a significant reduction in urinary albumin/creatinine ratio as well as significant reduction in uric acid production. Thus cilnidipine is more useful than amlodipine in improving albuminuria and uric acid metabolism in hypertensive patients with CKD.
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 01 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 10 Month 31 Day
Date of closure to data entry
2011 Year 12 Month 31 Day
Date trial data considered complete
2011 Year 12 Month 31 Day
Date analysis concluded
2012 Year 03 Month 31 Day

Other
Other related information Journal: Journal of Clinical Hypertension

Article title: "Effects of the N/L-Type Calcium Channel Blocker Cilnidipine on Nephropathy and Uric Acid Metabolism in Hypertensive Patients with Chronic Kidney Disease (J-CIRCLE Study)."

Management information
Registered date
2010 Year 07 Month 27 Day
Last modified on
2014 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004744

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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