UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003956 |
|---|---|
| Receipt number | 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 11:58:30 |
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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
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
s_uchida@netjoy.ne.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004744
