UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006026 |
|---|---|
| Receipt number | R000007132 |
| Scientific Title | Effects of anti-viral drug (vidarabine) on atrial fibrillation and ventricular arrhythmia |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2020/03/02 10:08:08 |
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Basic information
Public title
Effects of anti-viral drug (vidarabine) on atrial fibrillation and ventricular arrhythmia
Acronym
Treatment of arrhythmia by vidarabine
Scientific Title
Effects of anti-viral drug (vidarabine) on atrial fibrillation and ventricular arrhythmia
Scientific Title:Acronym
Treatment of arrhythmia by vidarabine
Region
| Japan |
Condition
Condition
Arrhythmia
Classification by specialty
| Medicine in general | Cardiology | Surgery in general |
| Pediatrics | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Vidarabine is used as an anti-viral drug for many years. Vidarabine was demonstrated to inhibit cardiac adenylyl cyclase activity. Recently, it has been demonstrated to be beneficial for the treatment of arrhythmia such as atrial fibrillation and ventricular arrhythmia. We will examine the effects of vidarabine on these arrhythmia in human.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Time to terminate the atrial fibrillation
2) The decrease number of ventricular arrhythmia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Effects for atrial arrhythmia
Interventions/Control_2
Effects for ventricular arrhythmia
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
| 0 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Afrial fibrillation
Ventricular arrhythmia
Key exclusion criteria
Central nervous disease
Severe liver dysfunction
Severe renal dysfunction
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Okumura, Yoshihiro Ishikawa |
Organization
Yokohama City University
Division name
Cardiovascular Research Institute
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan, 236-0004
TEL
045-787-2575
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Ichikawa |
Organization
Yokohama City University
Division name
Cardiovascular Research Institute
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan, 236-0004
TEL
045-787-2575
Homepage URL
http://www-user.yokohama-cu.ac.jp/~seiri1/index.html
junseiri@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University,Cardiovascular Research Institute
Institute
Department
Personal name
Funding Source
Organization
Cardiovascular Research Institute, Yokohama City University
Organization
Division
Category of Funding 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
| 2011 | 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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 22 | Day |
Last modified on
| 2020 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007132
