UMIN-CTR Clinical Trial

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

Primary Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Internal Medicine, Kanazawa University Hospital Disease Control and Homeostasis

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Kanazawa Municipal Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

金沢大学附属病院(石川県)、金沢市立病院(石川県)

Date of disclosure of the study information

2012

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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