UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008553 |
|---|---|
| Receipt number | R000010052 |
| Scientific Title | Randomized, closs-over study to compare the effect of cilnidipine and azelnidipine on microalbuminuria in patients with hypertension and chronic kidney disease |
| Date of disclosure of the study information | 2012/07/30 |
| Last modified on | 2012/07/27 20:44:26 |
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Basic information
Public title
Randomized, closs-over study to compare the effect of cilnidipine and azelnidipine on microalbuminuria in patients with hypertension and chronic kidney disease
Acronym
Randomized, closs-over study to compare the effect of cilnidipine and azelnidipine on microalbuminuria in patients with hypertension and chronic kidney disease
Scientific Title
Randomized, closs-over study to compare the effect of cilnidipine and azelnidipine on microalbuminuria in patients with hypertension and chronic kidney disease
Scientific Title:Acronym
Randomized, closs-over study to compare the effect of cilnidipine and azelnidipine on microalbuminuria in patients with hypertension and chronic kidney disease
Region
| Japan |
Condition
Condition
hypertensive patients with chronic kidney disease
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the effect of cilnidipine and azelnidipine in association with reduction of urinary albumin-creatinine ratio in patients with hypertension and chronic kidney disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Urinary albumin-creatinie ratio(mg/g*Cr) after 12 and 24 weeks
Key secondary outcomes
Clinical blood pressure and heart rate
Mean home blood pressure
Estimated glomerular filtration rate
Plasma Renin Activity, Plasma Aldosterone Concentration
Antihypertensive effect
Safety parameters
will be analized after 12 and 24 weeks
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cilnidipine(initial dose is 10mg/day, 5-20mg/day)
Interventions/Control_2
azelnidipine(initial dose is 8mg/day, 4-16mg/day)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hypertension patients with chronic kidney disease (CKD)
*Chronic kidney disease is defined as either kidney damage or GFR<60ml/min/1.73m^2 for 3months.
Kidney damage is defined as pathologic abnormalities or markers of damage, including abnormalities in blood or urine tests or imaging studies.
Patients who administer angiotensin receptor blocker(ARB) and amlodipine as calcium blocker.
Key exclusion criteria
1) Contraindication to calcium chanel blockers.
2) Patients who has already administered calcium channel blocker except for amlodipine.
3) Any serious comobidity(brain disease, heart disease, renal disease, hepatic disease)
4) The patients with pregnant or possibly pregnant
5) Sereous hypertension patients
6) Investigator judged as inappropriate for this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nakajima |
Organization
Mie University, Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
Address
2-174, Edobashi, Tsu-city, Mie, Japan
TEL
(059)231-5015
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Taniguchi |
Organization
Mie University, Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
Address
2-174, Edobashi, Tsu-city, Mie, Japan
TEL
(059)231-5015
Homepage URL
Sponsor or person
Institute
Department of Cardiology and Nephrology, Mie University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology and Nephrology, Mie University, Graduate School of Medicine
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
三重大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 30 | 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
| 2012 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 30 | 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
| 2012 | Year | 07 | Month | 27 | Day |
Last modified on
| 2012 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010052
