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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003104
Receipt No. 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

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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
Email

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/
Email inano-heart@bpost.plala.or.jp

Sponsor
Institute APDD
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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