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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000496
Receipt No. R000000596
Scientific Title Cilnidipine versus Amlodipine Randomized Trial for Evaluation in Renal Desease
Date of disclosure of the study information 2006/10/04
Last modified on 2006/10/10

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Basic information
Public title Cilnidipine versus Amlodipine Randomized Trial for Evaluation in Renal Desease
Acronym CARTER
Scientific Title Cilnidipine versus Amlodipine Randomized Trial for Evaluation in Renal Desease
Scientific Title:Acronym CARTER
Region
Japan

Condition
Condition hypertensive patients with renal disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare between renoprotective effect of cilnidipine, a L+N type calcium channel blocker (CCB), and amlodipine, a L type CCB, in combination with angiotensin receptor blocker or angiotensin converting enzyme inhibitor on treatment of hypertensive patients with renal disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Urinary protein as protein/creatinine ratio
Key secondary outcomes Cardiovascular death
Cardiovascular event

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 NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 cilnidine 10-20mg/day in combination with angiotensin receptor blocker (ARB) or angiotensin converting enzyme (ACE)inhibitor
Interventions/Control_2 amlodipine 5-10 mg/day in combination with ARB or ACEinhibitor
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Urinary protein is 300mg/gCr and above
2. Serum creatinine is 3.0 mg/dl and below
3. Blood pressure is 130/85 mmHg and above
4. Patients who give a written informed consent
5. Patients who have been administered angiotensin receptor blocker (ABR) or angiotensin converting enzyme (ACE) inhibitor during 2-3 months and above

Key exclusion criteria 1. Hypertensive emergency
2. Severe heart failure, severe arrhythmia, angina, myocardial infarction within 6 months of onset
3. Stroke within 6 months of onset
4. Severe diabetes mellitus
5. Prengnancy and possible pregnancy
6. History of severe side effect of calcium channel blocker, ARB, or ACE inhibitor
7. Patients who are treateing with cilnidipine or amlodipine
8. Patinets who are inadequate to entry this study by physicians in charge
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiro Fujita
Organization University of Tokyo Graduate School of Medicine
Division name Department of Nephrology and Endocrinology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655
TEL 03-5800-9119
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Ando
Organization University of Tokyo Graduate School of Medicine
Division name Molecular and Cardiovascular Metabolism
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655
TEL 03-5800-9119
Homepage URL
Email

Sponsor
Institute University of Tokyo Graduate School of Medicine
Institute
Department

Funding Source
Organization Department account fund
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

Other administrative information
Date of disclosure of the study information
2006 Year 10 Month 04 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 Completed
Date of protocol fixation
2002 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2002 Year 07 Month 01 Day
Last follow-up date
2006 Year 07 Month 01 Day
Date of closure to data entry
2006 Year 10 Month 01 Day
Date trial data considered complete
2006 Year 10 Month 01 Day
Date analysis concluded
2006 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 10 Month 03 Day
Last modified on
2006 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000596

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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