UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004346 |
|---|---|
| Receipt number | R000005200 |
| Scientific Title | The clinical test to evaluate the effective and safety dosage of dantrolene for the treatment of ventricular tachycardia in patients with heart disease |
| Date of disclosure of the study information | 2010/10/15 |
| Last modified on | 2010/10/06 19:27:09 |
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Basic information
Public title
The clinical test to evaluate the effective and safety dosage of dantrolene for the treatment of ventricular tachycardia in patients with heart disease
Acronym
dantrolene study
Scientific Title
The clinical test to evaluate the effective and safety dosage of dantrolene for the treatment of ventricular tachycardia in patients with heart disease
Scientific Title:Acronym
dantrolene study
Region
| Japan |
Condition
Condition
Ventricular tachycardia
(CPVT, ARVC, Heart failure)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
of dantrolene for the treatment of ventricular tachycardia in patients with heart diseaseto evaluate the effective and safety dosage
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to investigate the effective and safety dosage of dantrolene for the treatment of ventricular tachycardia in patients with heart disease
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dantrolene
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ventricular tachycardia accompanyed with heart failure(old myocardial infarction, cardiac sarcoidosis, DCM, HCM)
CPVT or ARVC
Key exclusion criteria
COPD
muscle dystrophy
patients with hepatic disease
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masunori Matsuzaki |
Organization
Yamaguchi University
Division name
Department of Medicine and Clinical Science
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2248
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeki Kobayashi |
Organization
Yamaguchi University
Division name
Department of Medicine and Clinical Science
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2248
Homepage URL
Sponsor or person
Institute
Department of Medicine and Clinical Science
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical Science
Yamaguchi University
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
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
| 2010 | Year | 10 | Month | 15 | 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
| 2010 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2010 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005200
