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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002431
Receipt No. R000002741
Scientific Title Preservation of Diastolic Function by Fenofibrate in Patients with Dyslipidemia
Date of disclosure of the study information 2009/09/02
Last modified on 2014/12/08

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Basic information
Public title Preservation of Diastolic Function by Fenofibrate in Patients with Dyslipidemia
Acronym Cardioprotective Effect of Fenofibrate
Scientific Title Preservation of Diastolic Function by Fenofibrate in Patients with Dyslipidemia
Scientific Title:Acronym Cardioprotective Effect of Fenofibrate
Region
Japan

Condition
Condition dyslipidemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate whether fenofibrate can ameliorate cardiac diastolic dysfunction in patients with dyslipidemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes diastolic function, serum lipid profile
Key secondary outcomes plasma glucose, HbA1c, urinary 8OHdG, urinary NOx, adiponectin

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Hyper TG patients will be administered with fenofibrate (67-200mg). They will be examined by UCG to assess the cardiac dysfunction.
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
30 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria high TG patients (over 150mg/dl)
Key exclusion criteria patients with systolic dysfunction (EF below 50%)
patients with renal disorders (serum creatinine 2.0mg/dl over)
patients with previous or current cancer
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken-ichi Aihara
Organization The University of Tokushima, Graduate School of Health Biosciences
Division name Medicine and Bioregulatory Sciences
Zip code
Address 3-18-15 Kuramoto-cho Tokushima
TEL 088-633-7120
Email aihara@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken-ichi Aihara
Organization The University of Tokushima, Graduate School of Health Biosciences
Division name Medicine and Bioregulatory Sciences
Zip code
Address 3-18-15 Kuramoto-cho Tokushima
TEL 088-633-7120
Homepage URL
Email aihara@clin.med.tokushima-u.ac.jp

Sponsor
Institute The University of Tokushima, Graduate School of Health Biosciences
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 徳島大学病院(徳島県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 02 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 Completed
Date of protocol fixation
2009 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 05 Month 01 Day
Date analysis concluded
2012 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 02 Day
Last modified on
2014 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002741

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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