UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002431 |
|---|---|
| Receipt number | 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 15:42:43 |
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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
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
aihara@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima, Graduate School of Health Biosciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002741
