UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009123 |
|---|---|
| Receipt number | R000009962 |
| Scientific Title | Inhibitory effect of azelnidipine on sympathetic nerve activity in hypertensive patients Evaluation of different class effect of calcium channel blocker by using muscle sympathetic nerve activity |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2014/04/16 20:26:37 |
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Basic information
Public title
Inhibitory effect of azelnidipine on sympathetic nerve activity in hypertensive patients
Evaluation of different class effect of calcium channel blocker by using muscle sympathetic nerve activity
Acronym
Evaluation of sympathetic nerve activity in hypertensive patients, taking hypotensive drugs, azelnidipine or amlodipine, by using muscle sympathetic nerve activity
Scientific Title
Inhibitory effect of azelnidipine on sympathetic nerve activity in hypertensive patients
Evaluation of different class effect of calcium channel blocker by using muscle sympathetic nerve activity
Scientific Title:Acronym
Evaluation of sympathetic nerve activity in hypertensive patients, taking hypotensive drugs, azelnidipine or amlodipine, by using muscle sympathetic nerve activity
Region
| Japan |
Condition
Condition
Primary Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the hypothesis that azelnidipine has inhibition effects on sympathetic nerve activity beyond reducing blood pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Each effect of azelnidipine and amlodipine on blood pressure and sympathetic nerve activity in hypertensive patients, 8 weeks after beginning of each administration
Key secondary outcomes
Each effect of azelnidipine and amlodipine on renal function, liver function, and cardiac function in hypertensive patients, 8 weeks after beginning of each administration
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Calcium channel blocker(CCB), azelnidipine(16mg) will be taken for 8weeks, and then the other CCB, amlodipine(5mg) for next 8weeks. Evaluation of cardiovascular parameters and muscle sympathetic nerve activity will be performed before and on the end of each drug intervention.
Interventions/Control_2
Amlodipine(5mg) will betaken for 8weeks, and then azelnidipine(16mg) for next 8weeks. Evaluation of cardiovascular parameters and muscle sympathetic nerve activity will be performed before and on the end of each drug intervention.
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
Hypertensive patients who have not received any antihypertensive treatment with drugs or received antihypertensive treatment with drugs except any calcium channel blocker or beta blocker
Key exclusion criteria
1.Patients who need drug medication for diabetes mellitus, heart failure or arrhythmia 2.Patients who have severe functional disturbance of liver or kidney 3.Patiens who have history of
apoplexy or undergoing operation with artificial vessel 4.Patients of secondary hypertension 5.Patients whose systolic blood pressure is over 200mmHg or diastolic blood pressure is over 120mmHg
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Internal Medicine, Kanazawa University Hospital
Division name
Disease Control and Homeostasis
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2238
jinomataj@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun-ichiro Inomata |
Organization
Internal Medicine, Kanazawa University Hospital
Division name
Disease Control and Homeostasis
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2238
Homepage URL
jinomataj@gmail.com
Sponsor or person
Institute
Internal Medicine, Kanazawa University Hospital Disease Control and Homeostasis
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
Kanazawa Municipal Hospital
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
金沢大学附属病院(石川県)、金沢市立病院(石川県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 01 | 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
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 06 | 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 | 10 | Month | 16 | Day |
Last modified on
| 2014 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009962
