UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000496 |
|---|---|
| Receipt number | 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 08:17:05 |
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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
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
Sponsor or person
Institute
University of Tokyo Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000596
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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