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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001764
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kagawa University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002086

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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