UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052353 |
|---|---|
| Receipt number | R000059770 |
| Scientific Title | Elucidation of pharmacokinetics of carvedilol and flecainide |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/09/29 17:29:55 |
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Basic information
Public title
Elucidation of pharmacokinetics of anti arrhythmic drugs
Acronym
Elucidation of pharmacokinetics of anti arrhythmic drugs
Scientific Title
Elucidation of pharmacokinetics of carvedilol and flecainide
Scientific Title:Acronym
Elucidation of pharmacokinetics of carvedilol and flecainide
Region
| Japan |
Condition
Condition
hypertension,heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The concentrations of carvedilol and flecainide in the cerebrospinal fluid are unknown and will be investigated.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlate the blood concentration of carvedilol and flecainide in the cerebrospinal fluid concentration
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients taking carvedilol and flecainide and for whom lumbar anesthesia is not contraindicated
Key exclusion criteria
Patients who cannot consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Ai |
Organization
Juntendo University Urayasu Hospital
Division name
Clinical Laboratory Medicine
Zip code
270-0021
Address
2-1-1 Tomioka,Urayasu,Chiba
TEL
047-353-3111
t-ai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Mirei |
| Middle name | |
| Last name | Kamimura |
Organization
Juntendo University Urayasu Hospital
Division name
Clinical Laboratory Medicine
Zip code
270-0021
Address
2-1-1 Tomioka,Urayasu,Chiba
TEL
047-353-3111
Homepage URL
m.kamimura.vo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
internal
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
Juntendo University Urayasu Hospital
Address
2-1-1 Tomioka,Urayasu,Chiba
Tel
047-353-3111
m.kamimura.vo@juntendo.ac.jp
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
| 2024 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes
Management information
Registered date
| 2023 | Year | 09 | Month | 29 | Day |
Last modified on
| 2023 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059770
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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