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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006854
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008072

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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