UMIN-CTR Clinical Trial

Public title

The effect of L/N type Calcium channel blocker on blood pressure variability in elderly hypertensive patients

Acronym

The effect of L/N type CCB on BP variability in elderly hypertensive patients

Scientific Title

The effect of L/N type Calcium channel blocker on blood pressure variability in elderly hypertensive patients

Scientific Title:Acronym

The effect of L/N type CCB on BP variability in elderly hypertensive patients

Region

Japan

Condition

Hypertension

Classification by specialty

Cardiology

Geriatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

While aging is known to increase blood pressure (BP) variability, recent studies have shown that the BP variability is an independent predictor of cardiovascular disease. Calcium channel blocker (CCB), one of the first choices of anti-hypertensive therapy, mediates its depressor effect via inhibition of L type Ca Channel. Cilnidipine is a Ca channel blocker that blocks not only L type Ca channel but also N type Ca channel that triggers synthetic nerve activation. As synthetic nerve activity is involved in the mechanism of BP variability, the blockade of N type Ca channel by Cilnidipine may contribute to change in BP variability. On the other hand, amlodipine is the most popular Ca channel blocker with little ability to inhibit N type Ca channel. In this study, elderly hypertensive patients are subjected to changeover administration in the order of cilnidipine, amlodipine, and cilnidipine to investigate the effect of N type Ca channel on blood pressure variability and sympathetic nerve system.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

(Comparison among step1, step2, and step3)
Home BP variability (interdaily variability, intradaily variability (morning, night) BP variability during sleep

Home pulse rate variability (interdaily variability, intradaily variability (morning, night) pulse rate variability during sleep

Key secondary outcomes

1.BP and pulse rate at outpatient (average of two measurements)
2.Index of oxidative stress
3.Renal function (Ualb/Cr. eGFR)
4.Sympathetic nerve activity

Study type

Interventional

Basic design

expanded access

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

cilnidipine

Interventions/Control_2

amlodipine

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

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Age 65 and over
2.Stable hypertensive patients who receive amlodipine (<140/90 at outpatient clinic or <135/85 at home) or hypertensive patients who do not receive amlodipine.
3.Patients give written informed consent after sufficient explanation
4.Patients who have received the same anti-hypertensive medication during 6months.

Key exclusion criteria

1.Secondary hypertension, malignant hypertension
2.Stroke or myocardial infarction during 6months
3.Coronary intervention during 6months
4.Congestive heart failure with NYHA class III or more
5.Aortic stenosis
6.Arterial fibrillation, arterial flutter or malignant arrhythmia
7.Severe hepatic injury
8.Sensitivity to trial drug
9.Excluded by physicians decision

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Koichi Yamamoto

Organization

Osaka university graduate school of medicine

Division name

The department of geriatric medicine and nephrology

Zip code

Address

2-2/B6 Yamadaoka Suita Osaka Japan

TEL

06-6879-3852

Email

kyamamoto@geriat.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Koichi Yamamoto

Organization

Osaka university graduate school of medicine

Division name

The department of geriatric medicine and nephrology

Zip code

Address

2-2/B6 Yamadaoka Suita Osaka Japan

TEL

06-6879-3852

Homepage URL

Email

kyamamoto@geriat.med.osaka-u.ac.jp

Institute

Osaka university graduate school of medicine
The department of geriatric medicine and nephrology

Institute

Department

Personal name

Organization

Osaka university graduate school of medicine
The department of geriatric medicine and nephrology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2014

Year

08

Month

20

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

Enrolling by invitation

Date of protocol fixation

2014

Year

08

Month

12

Day

Date of IRB

Anticipated trial start date

2014

Year

08

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

08

Month

12

Day

Last modified on

2014

Year

08

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016090