UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033745 |
|---|---|
| Receipt number | R000038490 |
| Scientific Title | Determination of CYP3A activity in patients using plasma amlodipine exposure and metabolism |
| Date of disclosure of the study information | 2018/08/14 |
| Last modified on | 2020/08/15 19:13:40 |
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Basic information
Public title
Determination of CYP3A activity in patients using plasma amlodipine exposure and metabolism
Acronym
Determination of CYP3A activity using plasma amlodipine exposure and metabolism
Scientific Title
Determination of CYP3A activity in patients using plasma amlodipine exposure and metabolism
Scientific Title:Acronym
Determination of CYP3A activity using plasma amlodipine exposure and metabolism
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aimed to investigate the relationships between endogenous CYP3A metrics including plasma 4beta-hydroxycholesterol and 25-hydroxyvitamin D, and plasma amlodipine exposure and metabolism parameters in patients with hypertension.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of CYP3A activity by determining amlodipine and its two metabolites (dehydroamlodipine and O-des[2-aminoethyl]-O-carboxymethyl dehydroamlodipine) in Human Plasma
Key secondary outcomes
Assessment of CYP3A activity by determining plasma 4beta-hydroxycholesterol as an endogenous CYP3A metric
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated with AML besylate tablets
Key exclusion criteria
Patients from whom written informed consent was not obtained
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Kawakami |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital Pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192, Japan.
TEL
053-435-2623
kawakami@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Naito |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital Pharmacy
Zip code
4313192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192, Japan.
TEL
053-435-2623
Homepage URL
naitou@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
This work was partially supported by HUSM Grant-in-Aid (2016 and 2017).
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192, Japan.
Tel
053-435-2623
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
16-018
Org. issuing International ID_1
Ethics Committee of Hamamatsu University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 14 | 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
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with amlodipine treatment are enrolled. Blood samples for determination of CYP3A metrics including 4beta-hydroxycholesterol and amlodipine and its metabolites in plasma are collected at 24 hours after the amlodipine treatment.
Management information
Registered date
| 2018 | Year | 08 | Month | 14 | Day |
Last modified on
| 2020 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038490
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
