UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041362 |
|---|---|
| Receipt number | R000047219 |
| Scientific Title | A study on donepezil pharmacokinetics and QT time |
| Date of disclosure of the study information | 2020/08/12 |
| Last modified on | 2022/02/11 11:27:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on donepezil pharmacokinetics and QT time
Acronym
A study on donepezil pharmacokinetics and QT time
Scientific Title
A study on donepezil pharmacokinetics and QT time
Scientific Title:Acronym
A study on donepezil pharmacokinetics and QT time
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether blood concentration of donepezil is associated with QT time in patients taking donepezil.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between blood concentration of donepezil and QT time.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Taking donepezil
Interventions/Control_2
Not taking donepezil
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
As of January 1, 2019, outpatients over 65 years of age who had Alzheimer's disease and underwent treatment with donepezil at Tarumizu Chuo Hospital.
Key exclusion criteria
Taking anti-arrhythmic medications, a history of cardiac surgery including pacemaker implantation, and renal failure requiring hemodialysis.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | So |
| Middle name | |
| Last name | Kuwahata |
Organization
Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Division name
Department of Cardiovascular Medicine
Zip code
8912124
Address
1-140 Kinko-cho, Tarumizu City, Kagoshima, Japan
TEL
0994325211
sokuwahata@ybb.ne.jp
Public contact
Name of contact person
| 1st name | So |
| Middle name | |
| Last name | Kuwahata |
Organization
Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Division name
Department of Cardiovascular Medicine
Zip code
8912124
Address
1-140 Kinko-cho, Tarumizu City, Kagoshima, Japan
TEL
0994325211
Homepage URL
sokuwahata@ybb.ne.jp
Sponsor or person
Institute
Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Address
1-140 Kinko-cho, Tarumizu City, Kagoshima, Japan
Tel
0994325211
tarumizuhp@tarumizumh.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
| 2020 | Year | 08 | Month | 12 | 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
60
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Data analysis delay
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
| 2019 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 09 | Day |
Last modified on
| 2022 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047219
