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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009123
Receipt No. 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

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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
Email 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
Email jinomataj@gmail.com

Sponsor
Institute Internal Medicine, Kanazawa University Hospital Disease Control and Homeostasis
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009962

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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