UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003104 |
|---|---|
| Receipt number | R000003658 |
| Scientific Title | Microdose clinical trial for prediction of interindividual variability of PK and PD in patients administered with atorvastatin, pravastatin, rosuvastitine or telmisartan |
| Date of disclosure of the study information | 2010/01/27 |
| Last modified on | 2011/07/27 10:09:05 |
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Basic information
Public title
Microdose clinical trial for prediction of interindividual variability of PK and PD in patients administered with atorvastatin, pravastatin, rosuvastitine or telmisartan
Acronym
Microdose clinical trial for prediction of interindividual variability of PK and PD in patients
Scientific Title
Microdose clinical trial for prediction of interindividual variability of PK and PD in patients administered with atorvastatin, pravastatin, rosuvastitine or telmisartan
Scientific Title:Acronym
Microdose clinical trial for prediction of interindividual variability of PK and PD in patients
Region
| Japan |
Condition
Condition
hypertension or hyperlipidemia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
to compare PK and genetic determinants in patients with known data in health subjects
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
PK parameters and genetic variations in patients compared with known data from healthy volunteers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration with lesser dose (100µg or one hundredth of therapeutic dose)
Interventions/Control_2
administration with therapeutics dose
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
patient is;
1) able to understand and willing to sign the informed consent.
2)diagnosed as hypertension or hyperlipidemia
Key exclusion criteria
Patients wiht any conditions that the investigators judged unsuitable for the study.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Kajinami |
Organization
Kanazawa Medical University
Division name
cardiology
Zip code
Address
1-1 daigaku Uchinada-machi, Kahoku-gun
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Inano Akihiro |
Organization
APDD
Division name
APDD
Zip code
Address
TEL
Homepage URL
http://www.apdd-jp.org/
inano-heart@bpost.plala.or.jp
Sponsor or person
Institute
APDD
Institute
Department
Personal name
Funding Source
Organization
NEDO
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
the University of Tokyo
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
金沢医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 27 | 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
| 2009 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | 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 | 01 | Month | 27 | Day |
Last modified on
| 2011 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003658
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
