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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014108
Receipt No. 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

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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
Email 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
Email tamukou@med.yokohama-cu.ac.jp

Sponsor
Institute Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016424

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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