UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028886 |
|---|---|
| Receipt number | R000033058 |
| Scientific Title | Study on Single Nucleotide Polymorphisms of Functional Proteins determining Absorption, Metabolism, and Excretion of Edoxaban. |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2020/03/02 14:33:24 |
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Basic information
Public title
Study on Single Nucleotide Polymorphisms of Functional Proteins determining Absorption, Metabolism, and Excretion of Edoxaban.
Acronym
Single Nucleotide Polymorphisms and Edoxaban.
Scientific Title
Study on Single Nucleotide Polymorphisms of Functional Proteins determining Absorption, Metabolism, and Excretion of Edoxaban.
Scientific Title:Acronym
Single Nucleotide Polymorphisms and Edoxaban.
Region
| Japan |
Condition
Condition
Non-valvular atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Pharmacological potency, side effect, and kinetics in body are influenced by single nucleotide polymorphisms of genes encoding key proteins controlling drug's absorption, metabolism and excretion. This study aims to examine the effect of these functional SNPs on edoxaban blood level and to consider the precision medicine to avoid its side effect.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examine the relationship between functional SNP in CYP3A5, ABCB1 and ABCG2 and blood levels of oral edoxaban and determine their influence.
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
Patients with non-valvular atrial fibrillation receiving oral edoxaban therapy
Key exclusion criteria
Those who cannot give informed consent
Patients younger than 20 years
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Horie |
Organization
Shiga University of Medical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
Tsukinowa-Seta, Ohtsu City
TEL
81-77-548-2213
horie@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Ashihara |
Organization
Shiga University of Medical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
Tsukinowa-Seta, Ohtsu City
TEL
81-77-548-2213
Homepage URL
tashihar@gmail.com
Sponsor or person
Institute
Department of Cardiovascular Medicine
Shiga University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo CO, Ltd.
Organization
Division
Category of Funding Organization
Profit 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
| 2017 | Year | 10 | 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
| 2017 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Preliminary study on apixaban metabolism was published this year.
Ueshima S et al. Impact of ABCB1, ABCG2, and CYP3A5 polymorphisms on plasma trough concentrations of apixaban in Japanese patients with atrial fibrillation. Pharmacogenet Genomics. 2017 Sep;27(9):329-336.
Part of the result from this study (SiDOAC-SNP) will be presented at the 84th Annual Meeting of Japanese Circulation Society (Kyoto).
Management information
Registered date
| 2017 | Year | 08 | Month | 29 | 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=R000033058
