UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024187 |
|---|---|
| Receipt number | R000027772 |
| Scientific Title | Effects of probucol and EPA on lipid component of HDL particles |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2019/04/02 16:23:16 |
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Basic information
Public title
Effects of probucol and EPA on lipid component of HDL particles
Acronym
Effects of probucol and EPA on lipid component of HDL particles
Scientific Title
Effects of probucol and EPA on lipid component of HDL particles
Scientific Title:Acronym
Effects of probucol and EPA on lipid component of HDL particles
Region
| Japan |
Condition
Condition
Familial Hypercholesterolemia
Dyslipidemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of changes of lipid species in HDL particles in patients with familial hypercholesterolemia and dyslipidemia after the treatment of probucol or EPA respectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of lipid species in HDL particles after the treatment of probucol or EPA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(A)Treatment of probucol(500mg/day)in patients with familial hypercholesterolemia for 4 weeks
(B)Treatment of EPA(1800mg/day) in patients with dyslipidemia for 4 weeks
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
(A)Probucol-treated group
Patients with familial hypercholesterolemia who does not take probucol
1)Hyper LDL-cholesterolemia
2)Taking lipid-lowering agents
3)LDL-c<200mg/dl
4)NYHA 1 or 2
5)>20 years old
6)AST<100IU/L, ALT<100IU/L, Cr<1.5mg/dL
7)Informed consent
(B) EPA-treated group
Patients with dyslipidemia who does not take EPA
1)>20 years old
2)Informed consent
Key exclusion criteria
(A)Probucol-treated group
1)Taken probucol previously
2)Taking cyclosporin
3)Allergic to probucol
4)TG>400 mg/dL
5)HbA1c>8%
6)Frequent multifocal premature ventricular contraction
7)Atrial fibrillation
8)QTc>450msec(male),>470msec(female)on the ECG
9)Congestive heart failure or unstable angina
10)Participating in other trials
11)Pregnant (or might be pregnant) or lactating
12)The doctor decided to be inadequate for participating in this trial
(B) EPA-treated group
1)Hemodialysis
2)Liver dysfunction
3)Active malignant diseases
4)Scheduled to undergo coronary angiography or CABG
5)Severe heart failure
6)ACS within 3 months
7)PCI or CABG within 3 months
8)HbA1c>8%
9)Secondary dyslipidemia or taking omega3 agents
10)Bleeding or bleeding tendency
11)Having past side effects for omega3 agents
12)Participating in other trials
13)Pregnant (or might be pregnant) or lactating
14)The doctor decided to be inadequate for participating in this trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Sakata |
Organization
Osaka University Graduate School of Medicine
Division name
Cardiology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3631
yasushisk@cardiology.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Ohama |
Organization
Osaka University Graduate School of Medicine
Division name
Cardiology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3633
Homepage URL
ohama@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Cardiology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Laboratory for Metabolomics, RIKEN Center for Integrative Medical Sciences
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
大阪大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 27 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027772
