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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001593
Receipt No. R000001895
Scientific Title Therapeutic effects of L/N type calcium channel blocker cilnidipine and L type calcium channel blockers on hypertensive patients with chronic kidney disease
Date of disclosure of the study information 2008/12/22
Last modified on 2015/06/19

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Basic information
Public title Therapeutic effects of L/N type calcium channel blocker cilnidipine and L type calcium channel blockers on hypertensive patients with chronic kidney disease
Acronym Therapeutic effects of L/N type calcium channel blocker cilnidipine and L type calcium channel blockers on hypertensive patients with chronic kidney disease
Scientific Title Therapeutic effects of L/N type calcium channel blocker cilnidipine and L type calcium channel blockers on hypertensive patients with chronic kidney disease
Scientific Title:Acronym Therapeutic effects of L/N type calcium channel blocker cilnidipine and L type calcium channel blockers on hypertensive patients with chronic kidney disease
Region
Japan

Condition
Condition Hypertension, Chronic kidney disease
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will compare L/N type calcium channel blocker cilnidipine with other L type calcium channel blockers concerning blood pressure profile including blood pressure levels, diurnal blood pressure rhythm, renal function, autonomic nerve activity, and markers of oxidative stress in hypertensive patients with chronic kidney disease who are already treated with inhibitors of renin-angiotensin system and calcium channel blockers other than cilnidipine.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1. Clinic blood pressure.
2. Ambulatory blood pressure monitoring.
3. Renal function: eGFR, urinary protein/albuminon excretion.
4. Renin-angiotensin system, inflammatory and oxidative stress markers, PRA, urinary angiotensinogen, plasma cathecholamine.
5. Cardiac function: BNP, UCG.
6. Vascular function: ABI/baPWV.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cilnidipine (L/N) group: Change already prescribed calcium channel blockers other than cilnidipine to daily dosing of cilnidipine 10 mg daily for 48 weeks, and dosage may be modulated accroding to the clinical parameters (cilnidipine 5-20 mg daily). Target blood pressure level is below 130/80 mmHg.
Interventions/Control_2 Control (L) group: Continue already prescribed calcium channel blockers other than cilnidipine for 48 weeks, and dosage may be modulated accroding to the clinical parameters. Target blood pressure level is below 130/80 mmHg.
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. Patients with chronic kidney disease stages 3, 4, and 5 (eGFR<=60 ml/min/1.73 m2),
2. who are already treated with inhibitors of renin-angiotensin system (ACEi and/or ARB),
3. and are also already treated with calcium channel blockers other than cilnidipine.


Key exclusion criteria 1. Patients already treated with cilnidipine,
2. History of hypersensitivity to cilnidipine,
3. Severe hypertension (clinic BP more than 180/100 mmHg),
4. Severe liver disorder, or severe biliary atresia,
5. Pregnant women, or women suspected of being pregnant.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouichi TAMURA
Organization Yokohama City University Graduate School of Medicine
Division name Deaprtment of Medical Science
Zip code
Address 3-9 Fukuura, kanazawa-ku, Yokohama 236-0004, Japan
TEL 045-787-2635
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi UMEMURA
Organization Yokohama City University Graduate School of Medicine
Division name Deaprtment of Medical Science
Zip code
Address 3-9 Fukuura, kanazawa-ku, Yokohama 236-0004, Japan
TEL 045-787-2633
Homepage URL
Email sumemura@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 Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
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
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
2008 Year 12 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/23959116
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 Completed
Date of protocol fixation
2008 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 12 Month 19 Day
Last modified on
2015 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001895

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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