UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006854 |
|---|---|
| Receipt number | R000008072 |
| Scientific Title | Effect of nifedipine CR on blood pressure and renal function in CKD patients versus Cilnidipine |
| Date of disclosure of the study information | 2011/12/07 |
| Last modified on | 2011/12/07 14:44:29 |
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Basic information
Public title
Effect of nifedipine CR on blood pressure and renal function in CKD patients versus Cilnidipine
Acronym
Effect of nifedipine CR on blood pressure and renal function in CKD patients versus Cilnidipine
Scientific Title
Effect of nifedipine CR on blood pressure and renal function in CKD patients versus Cilnidipine
Scientific Title:Acronym
Effect of nifedipine CR on blood pressure and renal function in CKD patients versus Cilnidipine
Region
| Japan |
Condition
Condition
chronic kidney disease, hypertension
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This will compare the beneficial or adverse effects of ARB-based combination therapy with L/N type CCB Cilnidipine and L type CCB NifedipineCR on clinic BP, home BP profile, kidney function, in hypertensive patients with chronic kidney disease who do not achieve the target BP that is recommended by JSH2009 guideline and CKD guideline 2009 using ARB-based combination therapy with L type CCB Amlodipine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.clinic BP
2.urinary albumin excretion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
Nifedipine CR group:
In the intervention phase, add-on combination therapy will be performed by nifedipine CR 40-60mg daily for 24 weeks .
Interventions/Control_2
Cilinidipine group:
In the intervention phase, add-on combination therapy will be performed by cilnidipine 10-20mg daily for 24 weeks .
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Chronic kidney disease stage 3 and 4
2) On ARB-based combination therapy with CCB amlodipine
3) Clinic SBP : <150mmHg and >= 130 mmHg, or clinic DBP: <100mmHg and >=80 mmHg.
Key exclusion criteria
1) Secondary hypertension
2) Diabetic nephropathy
3) Schedule of dialysis induction within one year
4) Cardiac shock
5) Pregnant or suspicious women.
6) History of hypersensitivity to nifedipine or cilinidipine.
7) Judged as inappropriate for the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masunori Matsuzaki |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Medicine and Clinical Science
Zip code
Address
1-1-1 Minamikogushi, Ube, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Medicine and Clinical Science
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
consigned research fund
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 12 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | 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
| 2011 | Year | 12 | Month | 07 | Day |
Last modified on
| 2011 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008072
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
