UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009158 |
|---|---|
| Receipt number | R000010741 |
| Scientific Title | AZELNIDIPINE COMBINED WITH ANGIOTENSIN RECEPTOR BLOCKER CAN RESTORE SYMPATHETIC ACTIVITY |
| Date of disclosure of the study information | 2012/10/21 |
| Last modified on | 2016/10/16 11:06:37 |
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Basic information
Public title
AZELNIDIPINE COMBINED WITH ANGIOTENSIN RECEPTOR BLOCKER CAN RESTORE SYMPATHETIC ACTIVITY
Acronym
Azelnidipine/ARB & Sympathetic activity
Scientific Title
AZELNIDIPINE COMBINED WITH ANGIOTENSIN RECEPTOR BLOCKER CAN RESTORE SYMPATHETIC ACTIVITY
Scientific Title:Acronym
Azelnidipine/ARB & Sympathetic activity
Region
| Japan |
Condition
Condition
Chronic Kidney Disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the combination antihypertensive regimen, olmesartan and azelnidipine, can restore sympathetic/parasympathetic activities in patients with CKD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Decrease in LF/HF, increase in HF and the attenuation of the non-Gaussianity index during 8-wk treatment with ARB/CCB
Key secondary outcomes
changes in proteinuria (mg/gCre) and office blood pressure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
concurrent treatment with olmesartan and azelnidipine
Interventions/Control_2
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
patients with CKD undergoing treatment with olmesartan for at least 2 months before enrollment
no medication with calcium channel blockers for at least 2 months before enrollment
Key exclusion criteria
1) polycystic kidney disease
2) arrhythmia
3) known history of angina pectoris, myocardial infarction, heart failure, stroke, or TIA
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio FUKUDA |
Organization
Nagoya City University Hospital
Division name
Division of Nephrology
Zip code
Address
Nagoya 467-8601, Japan
TEL
81-52-853-8221
m-fukuda@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio FUKUDA |
Organization
Nagoya City University Hospital
Division name
Division of Nephrology
Zip code
Address
Nagoya 467-8601, Japan
TEL
81-52-853-8221
Homepage URL
m-fukuda@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Division of Nephrology, Nafoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
NONE
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
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
名古屋市立大学病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Means of all normal-to-normal intervals over 24 h (p<0.0001) and DC (p=0.002) increased, and Lambda (p=0.001) decreased regardless of gender, age, renal function or blood pressure, while no significant changes were observed in the other HRVs.
Reduction of Lambda is useful to assess the effect of sympathoinhibitory treatment.
J Renin Angiotensin Aldosterone Syst. 2016 Apr 18;17(2):1470320316643905
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
| 2012 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 21 | Day |
Last modified on
| 2016 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010741
