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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006018
Receipt No. R000007123
Scientific Title An observational study examining bioactive substances and genetic polymorphism for personalized pharmacotherapy in hyperlipidemia
Date of disclosure of the study information 2011/07/21
Last modified on 2014/01/24

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Basic information
Public title An observational study examining bioactive substances and genetic polymorphism for personalized pharmacotherapy in hyperlipidemia
Acronym Examination of bioactive substances and genetic polymorphism for personalized pharmacotherapy in hyperlipidemia
Scientific Title An observational study examining bioactive substances and genetic polymorphism for personalized pharmacotherapy in hyperlipidemia
Scientific Title:Acronym Examination of bioactive substances and genetic polymorphism for personalized pharmacotherapy in hyperlipidemia
Region
Japan

Condition
Condition Hyperlipidemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To examine bioactive substances and genetic polymorphism for personalized pharmacotherapy in hyperlipidemia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy and safety of lipid-lowering drugs
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 hyperlipidemia who provide written informed consent
Key exclusion criteria 1) minors
2) Patients with no written informed consent
3) Patients with past history of drug allergy
4) Patients who are inadequate for drug usage
5) Patients with abnormal values of laboratory tests
6) Pregnant women, or nursing women
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Yoshiyama
Organization Osaka City University Graduate School of Medicine
Division name Department of Internal medicine and Cardiology
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka City, Osaka, Japan
TEL 06-6645-3800
Email yoshiyama@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Yoshiyama
Organization Osaka City University Graduate School of Medicine
Division name Department of Internal medicine and Cardiology
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka City, Osaka, Japan
TEL 06-6645-3800
Homepage URL
Email yatakemoto@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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
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

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 21 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 Open public recruiting
Date of protocol fixation
2010 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 06 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 Observing relations between changes of biochemical indices, bioactive substances, genetic polymorphism and efficacy or safety of lipid-lowering agents

Management information
Registered date
2011 Year 07 Month 21 Day
Last modified on
2014 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007123

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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