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
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
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
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
