UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000935
Receipt No. R000000995
Scientific Title Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate or EPA in type 2 diabetic patients with hyperlipidemia.
Date of disclosure of the study information 2008/09/01
Last modified on 2007/12/06

* 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 Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate or EPA in type 2 diabetic patients with hyperlipidemia.
Acronym Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate or EPA in type 2 diabetic patients with hyperlipidemia.
Scientific Title Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate or EPA in type 2 diabetic patients with hyperlipidemia.
Scientific Title:Acronym Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate or EPA in type 2 diabetic patients with hyperlipidemia.
Region
Japan

Condition
Condition type 2 diabetic patients with hyperlipidemia
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate in type 2 diabetic patients with hyperlipidemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes % change in TG, HDL-C and LDL-C at 24 weeks
Key secondary outcomes Include assesment of ALT, SCr, CK(CPK) and at 24 weeks
Change of the concentration of serum rosuvastatin at 24 weeks

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Following a 8 weeks medication with rosuvastatin 2.5mg, subjects with not achieved NCEP ATPIII goal will be receive treatment with fenofibrate 200-201mg for 24 weeks.
Interventions/Control_2 Following a 8 weeks medication with rosuvastatin 2.5mg, subjects with not achieved NCEP ATPIII goal will be receive treatment with EPA 1800mg for 24 weeks.
Interventions/Control_3 Following a 8 weeks medication with fenofibrate 200-201mg, subjects with not achieved NCEP ATPIII goal will be receive treatment with rosuvastatin 2.5mg for 24 weeks.
Interventions/Control_4 Following a 8 weeks medication with EPA 1800mg, subjects with not achieved NCEP ATPIII goal will be receive treatment with rosuvastatin 2.5mg for 24 weeks.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetic patients taking medication with rosuvastatin 2.5mg or fenofibrate 200-201mg or EPA 1800mg more than 8 weeks but not achieved NCEP ATPIII goals.
Key exclusion criteria The patient with liver or kidney disfunction or abnormality of CK
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuoki Kohono
Organization Hiroshima University Graduate School of Biomedical Sciences Department of Molecular and Internal Medicine
Division name Division of Clinical Medical Science Programs for Applied Biomedicine
Zip code
Address 1-2-3Kasumi, Minami-ku Hiroshima Japan
TEL 082-257-5196
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Watanabe
Organization Hiroshima University Hospital
Division name Department of Endoclinology
Zip code
Address 1-2-3Kasumi, Minami-ku Hiroshima Japan
TEL 082-257-5196
Homepage URL
Email drhiroshi@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital Department of Endoclinology
Institute
Department

Funding Source
Organization None
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
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
2008 Year 09 Month 01 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
Date of protocol fixation
2007 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 12 Month 06 Day
Last modified on
2007 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000995

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.