UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014108 |
|---|---|
| Receipt number | R000016424 |
| Scientific Title | Comparative study on hypotensive effect by administration timing of L/N-type calcium channel blocker cilnidipine in chronic kidney disease patients |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2014/05/29 16:09:54 |
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Basic information
Public title
Comparative study on hypotensive effect by administration timing of L/N-type calcium channel blocker cilnidipine in chronic kidney disease patients
Acronym
Hypotensive effect by administration timing of cilnidipine in chronic kidney disease patients
Scientific Title
Comparative study on hypotensive effect by administration timing of L/N-type calcium channel blocker cilnidipine in chronic kidney disease patients
Scientific Title:Acronym
Hypotensive effect by administration timing of cilnidipine in chronic kidney disease patients
Region
| Japan |
Condition
Condition
Hypertension with chronic kidney disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to elucidate the improvement effect of adjustment at medication time of cilnidipine for CKD patients with hypertension.
It is expected that the different medication time of cilnidipine may cause the different effect on diurnal blood pressure variation characteristics.
We randomly assign medication time of cilnidipine to two groups (morning internal use group and night internal use group), then continue 24 weeks medication.
We evaluate the improvement effect for diurnal blood pressure variation characteristics and cardiovascular kidney protection in these groups by ambulatory blood pressure monitoring (ABPM) and other examinations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ambulatory blood pressure monitoring (ABPM)
Key secondary outcomes
1)BW, obesity, abdominal circumference.
2)Clinical blood pressure
3)Renal function
4)Cardiovascular function(Echocardiographic study, AI, ABI/baPWV), CAVI, Sympathetic nerve activity)
5)Blood examination
6)Lipid metabolism
7)Inflammatory marker
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
morning internal use group:patients are given 5-20mg of cilnidipine in morning.
Interventions/Control_2
night internal use group:patients are given 5-20mg of cilnidipine at bedtime.
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.CKD stage G1-5.
2.Hypertension:systolic blood pressure 130 mmHg or diastolic blood pressure 80 mmHg.
Key exclusion criteria
1.Dialysis patients.
2.Clinical blood pressure is 180/100mmHg or more in antihypertensive treatment.
3.Patients already received cilnidipine.
4.Patients with a history of hypersensitivity to cilnidipine.
5.Pregnant women or women who are suspect of pregnancy.
6.Patients judged as inappropriate for the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouichi Tamura |
Organization
Yokohama City University School of Medicine
Division name
Department of Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2635
tamukou@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouichi Tamura |
Organization
Yokohama City University School of Medicine
Division name
Department of Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2635
Homepage URL
tamukou@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | 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
| 2014 | Year | 05 | Month | 29 | Day |
Last modified on
| 2014 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016424
