UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010242 |
|---|---|
| Receipt number | R000011756 |
| Scientific Title | Comparison of additive effect of omega-3 fatty acid or ezetimibe in combination with statins on the reduction of small dense LDL in patients with coronary artery disease |
| Date of disclosure of the study information | 2013/03/15 |
| Last modified on | 2018/06/28 09:26:05 |
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Basic information
Public title
Comparison of additive effect of omega-3 fatty acid or ezetimibe in combination with statins on the reduction of small dense LDL in patients with coronary artery disease
Acronym
Comparison of additive effect of omega-3 fatty acid or ezetimibe in combination with statins on the reduction of small dense LDL in patients with coronary artery disease
Scientific Title
Comparison of additive effect of omega-3 fatty acid or ezetimibe in combination with statins on the reduction of small dense LDL in patients with coronary artery disease
Scientific Title:Acronym
Comparison of additive effect of omega-3 fatty acid or ezetimibe in combination with statins on the reduction of small dense LDL in patients with coronary artery disease
Region
| Japan |
Condition
Condition
Uncontrolled dyslipiemic patients with coronary artery disease under statin use
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate additive effects of omega-3 fatty acid or ezetimibe in combination with statins on the reduction of small dense LDL in patients with coronary artery disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in small dense LDL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Omega-3 fatty
Interventions/Control_2
Ezetimib
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
1)adults over 20 years old
2)HbA1c less than 9%
3)Change in HbA1c plus/minus 1% during last 3 months
Key exclusion criteria
1)TG>=400mg/dL
2)Patients receiving insulin therapy
3)Pregnant woman or possibly pregnant woman
4)Patients having allergy for study drug
5)Active hepatitis or liver cirrhosis
6)Serum creatinine >2mg/dL
7)Patients suffered from acute coronary syndrome or stroke last 3 months
8)Secondary hyperlipidemia, drug-induced hyperlipidemia, familial hyperlipidemia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ito |
Organization
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
miyoshit@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1 Shikada-cho Kita-ku Okayama
TEL
086-235-7351
Homepage URL
miyoshit@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences, Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 15 | 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
| 2013 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 14 | Day |
Last modified on
| 2018 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011756
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
