UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003695 |
|---|---|
| Receipt number | R000004452 |
| Scientific Title | Ambulatory blood pressure control and home blood pressure (morning and evening) lowering by N-channel blocker cilnidipine study |
| Date of disclosure of the study information | 2010/06/04 |
| Last modified on | 2011/05/09 13:50:37 |
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Basic information
Public title
Ambulatory blood pressure control and home blood pressure (morning and evening) lowering by N-channel blocker cilnidipine study
Acronym
Ambulatory blood pressure control and home blood pressure (morning and evening) lowering by N-channel blocker cilnidipine study (ACHIEVE ONE)
Scientific Title
Ambulatory blood pressure control and home blood pressure (morning and evening) lowering by N-channel blocker cilnidipine study
Scientific Title:Acronym
Ambulatory blood pressure control and home blood pressure (morning and evening) lowering by N-channel blocker cilnidipine study (ACHIEVE ONE)
Region
| Japan |
Condition
Condition
Essential Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of L/N-type Ca2+ channel blocker, Atelec tablet, on the blood pressure levels at home (especially early morning).
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 at home (early morning and before bedtime) or in physician's office
Key secondary outcomes
Adverse events
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
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 | Kazuomi Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
3311-1 Yakushiji, Shimonotsuke, Tochigi 329-0498, Japan
TEL
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
| 2010 | Year | 06 | Month | 04 | 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
Completed
Date of protocol fixation
| 2008 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective observational study was designed to investigate the effect of the Atelec on blood pressure levels measured either at home (early morning and before bedtime) or in physician's office. Patients were registered by the Patient Registration Center System.
Management information
Registered date
| 2010 | Year | 06 | Month | 02 | 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=R000004452
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
