UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001764 |
|---|---|
| Receipt number | R000002086 |
| Scientific Title | Appropriate Timing to Take Anti-Hypertensive Medicine Treating Morning Hypertension in Patients with Cerebral Infarction |
| Date of disclosure of the study information | 2009/03/11 |
| Last modified on | 2009/09/11 09:23:31 |
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Basic information
Public title
Appropriate Timing to Take Anti-Hypertensive Medicine Treating Morning Hypertension in Patients with Cerebral Infarction
Acronym
ATTACI
Scientific Title
Appropriate Timing to Take Anti-Hypertensive Medicine Treating Morning Hypertension in Patients with Cerebral Infarction
Scientific Title:Acronym
ATTACI
Region
| Japan |
Condition
Condition
Morning hypertension
Cerebral Infarction
Classification by specialty
| Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine the appropriate timing of anti-hypertensive medication to treat morning hypertension in the patients with cerebral infarction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of blood pressure at home.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
once after breakfast
calcium channel blocker (amlodipine 5mg)
ACE inhibitor (perindopril 4mg)
ARB (candesartan 8mg, olmesartan 20mg, valsartan 80mg, telmisartan 40mg)
Interventions/Control_2
once after dinner
calcium channel blocker (amlodipine 5mg)
ACE inhibitor (perindopril 4mg)
ARB (candesartan 8mg, olmesartan 20mg, valsartan 80mg, telmisartan 40mg)
Interventions/Control_3
once at bed
calcium channel blocker (amlodipine 5mg)
ACE inhibitor (perindopril 4mg)
ARB (candesartan 8mg, olmesartan 20mg, valsartan 80mg, telmisartan 40mg)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) previous ischemic stroke history
2) morning hypertension (>= 135/85 mmHg in mean of morning and evening blood pressure, and morning blood pressure - evening blood pressure >= 15 mmHg)
3) ability of continuous home blood pressure monitoring
Key exclusion criteria
1) low compliance
2) more than 75% carotid artery stenosis
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohisa Hosomi |
Organization
Kagawa University School of Medicine
Division name
Department of Cardiorenal and Cerebrovascular Medicine
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kagawa University School of Medicine
Division name
Department of Cardiorenal and Cerebrovascular Medicine
Zip code
Address
TEL
087-891-2153
Homepage URL
Sponsor or person
Institute
Kagawa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kagawa University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 03 | Month | 11 | 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 | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 11 | Day |
Last modified on
| 2009 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002086
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
