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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010560
Receipt No. R000012275
Scientific Title Research on the preventive effect of the atrial fibrillation by febuxostat
Date of disclosure of the study information 2014/04/01
Last modified on 2013/04/22

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Basic information
Public title Research on the preventive effect of the atrial fibrillation by febuxostat
Acronym Research on the preventive effect of the atrial fibrillation by febuxostat
Scientific Title Research on the preventive effect of the atrial fibrillation by febuxostat
Scientific Title:Acronym Research on the preventive effect of the atrial fibrillation by febuxostat
Region
Japan

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

Objectives
Narrative objectives1 The purpuse of this research is verifing whether febuxostat prevent the incidence of atrial fibrilation via reduction of cardiac oxidative stress
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reduction of incidence of atrial fibrillation
Shortning of duration of atrial fibrillation
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (a) Hyperuricemia (serum urinaric acid level is over 7.0 mg/dl)
(b) The patient with apparent attakck of paroxysmal atrial fibrillation
(c) The patient aged 20 and over in the time of consent acquisition
(d) The document consent by a free intention was obtained.
(e) An outpatient and an inpatient
Key exclusion criteria (a) persistent and permanent AF
(b) The patient who was new-prescribed in an ACE inhibitor or ARB within six months recently. A patient who had the quantity of an ACE inhibitor or ARB increased within six months.
(c) The patient who has mitral stenosis more than the degree of moderate class
(d) The patient who received catheter ablation during less than three months or research period.
(e) The patient already medicated with allopurinol.
(f) A patient with the past of the hypersensitivity to the medicine
(g)The patient who has liver disease (AST or ALT >100U)
(h)The patient who has a severe renal failure (BUN >30mg/dL, Serum creatinin >2.5mg/dL)
(i) The patient under administration of azathioprine, vidarabine and didanosine (contraindications)
(j) A woman under pregnancy or with the possibility of pregnancy
(k) The woman under breast-feeding
(l) The patient who received medication of other trial drugs within three months before the medication
(m) In addition, the patient who judged that a chief (assignment) researcher was unsuitable as a subject
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotaka Yada
Organization National defense medical college
Division name Cardiology
Zip code
Address 3-2 Namiki, Tokorozawa, Saitama, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National defense medical college
Division name Cardiology
Zip code
Address
TEL 04-2995-1511
Homepage URL
Email

Sponsor
Institute Cardiology, National defense medical college
Institute
Department

Funding Source
Organization TEIJIN PHARMA
Organization
Division
Category of Funding Organization Other
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 防衛医科大学校病院 (埼玉県)

Other administrative information
Date of disclosure of the study information
2014 Year 04 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 Enrolling by invitation
Date of protocol fixation
2012 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We check blood pressure, pulse rate, blood test, a urine test, chest X-rays, 12 leads electrocardiogram, UCG, the Holter electrocardiogram, and all the efficacy evaluation items of the questionnaire of an arrhythmic attack at the time of a medical treatment start, 6 or 12 months.

Management information
Registered date
2013 Year 04 Month 22 Day
Last modified on
2013 Year 04 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012275

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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