UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005523
Receipt number R000006548
Scientific Title Effects of the N-type Ca2+ channel blocker, Cilnidipine: Atelec®, on blood pressure levels and atherosclerosis indices in hypertensive patients with cerebrovascular disease.
Date of disclosure of the study information 2011/04/28
Last modified on 2011/05/09 13:51:11

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Basic information

Public title

Effects of the N-type Ca2+ channel blocker, Cilnidipine: Atelec®, on blood pressure levels and atherosclerosis indices in hypertensive patients with cerebrovascular disease.

Acronym

Carotid Atherosclerosis- Antihypertensive Treatment Trial, Effect of N-type CCB for cerebrovascular Disease (CA-ATTEND).

Scientific Title

Effects of the N-type Ca2+ channel blocker, Cilnidipine: Atelec®, on blood pressure levels and atherosclerosis indices in hypertensive patients with cerebrovascular disease.

Scientific Title:Acronym

Carotid Atherosclerosis- Antihypertensive Treatment Trial, Effect of N-type CCB for cerebrovascular Disease (CA-ATTEND).

Region

Japan


Condition

Condition

Essential Hypertension

Classification by specialty

Medicine in general Cardiology Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study effects of the N-type Ca2+ channel blocker, Cilnidipine: Atelec®, on blood pressure levels and atherosclerosis indices in hypertensive patients with cerebrovascular disease.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in blood pressure levels

Key secondary outcomes

Adverse events, changes of atherosclerosis indices.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Atelec-naive patients with essential hypertension and cerebrovascular disease.

Key exclusion criteria

Pregnant or possibly pregnant patients.

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayasu Matsumoto

Organization

Hiroshima University

Division name

Department of Clinical Neuroscience and Therapeutics, Division of Integrated Medical Science, Programs for Biomedical Research, Graduate School of Biomedical Sciences

Zip code


Address

1-2-3, Kasumi, Minami-ku, Hiroshima 734-0037, Japan

TEL

082-257-5201

Email



Public contact

Name of contact person

1st name
Middle name
Last name Eiichi Ohara

Organization

Mochida Pharmaceutical Co., Ltd.

Division name

Post-Marketing Surveillance

Zip code


Address

1-7 Yotsuya, Shinjyuku-ku, Tokyo 160-8515 Japan

TEL

03-3225-6342

Homepage URL


Email

atelec.ms.tokutei@mochida.co.jp


Sponsor or person

Institute

Ajinomoto Pharmaceuticals Co., LTD.

Institute

Department

Personal name



Funding Source

Organization

Mochida Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 28 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

Open public recruiting

Date of protocol fixation

2011 Year 03 Month 17 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date

2014 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is conducted prospectively and observationally. Patients are registered by the Patient Registration Center System.


Management information

Registered date

2011 Year 04 Month 28 Day

Last modified on

2011 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006548


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name