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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005523
Receipt No. 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

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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
Institute Ajinomoto Pharmaceuticals Co., LTD.
Institute
Department

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
URL(English) https://upload.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


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