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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000016
Receipt No. R000000032
Scientific Title Effects of low dose warfarin and losartan especially in old patients with nonvaluvular atrial fibrillation
Date of disclosure of the study information 2007/08/01
Last modified on 2009/08/08

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Basic information
Public title Effects of low dose warfarin and losartan especially in old patients with nonvaluvular atrial fibrillation
Acronym HAKODATE atrial fibrillation study
Scientific Title Effects of low dose warfarin and losartan especially in old patients with nonvaluvular atrial fibrillation
Scientific Title:Acronym HAKODATE atrial fibrillation study
Region
Japan

Condition
Condition nonvaluvular atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the efficiency and safety of low-dose warfarin with losartan, especially in old patients with nonvalvular atrial fibrillation in a prospective, randamized multicenter trial
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes embolism
major bleeding
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 minimum-dose warfarin(INR1.5-1.9)
Interventions/Control_2 minimum-dose warfarin(INR1.5-1.9) with losartan 50mg
Interventions/Control_3 low-dose warfarin(INR2.0-2.4)
Interventions/Control_4 low-dose warfarin(INR2.0-2.4) with losartan 50mg
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 all(no age limitation) nonvalvular atrial fibrillation
Key exclusion criteria risk of major bleeding
cancer
dementia
severe liver dysfunction
severe renal dysfunction

Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Nakajima
Organization Nakajima clinic
Division name Nakajima clinic
Zip code
Address 19-13, Omori-cho, Hakodate, Hokkaido, 040-0034, Japan
TEL 0138-22-4357
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hakodate atrial fibrillation study group
Division name Hakodate atrial fibrillation study group
Zip code
Address 19-13, Omori-cho, Hakodate, Hokkaido, 040-0034, Japan
TEL 0138-22-4357
Homepage URL
Email shigshig@cocoa.ocn.ne.jp

Sponsor
Institute Nakajima clinic
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor none
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
2007 Year 08 Month 01 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 No longer recruiting
Date of protocol fixation
2005 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2005 Year 07 Month 01 Day
Last follow-up date
2007 Year 06 Month 01 Day
Date of closure to data entry
2007 Year 10 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 06 Month 27 Day
Last modified on
2009 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000032

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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