UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Hiroshi Ito
Organization	Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name	Cardiovascular Medicine
Address	2-5-1, Shikata-cho, Kita-ku, Okayama
TEL	086-235-7351
Email	miyoshit@cc.okayama-u.ac.jp

Public contact
Name of contact person	Toru Miyoshi
Organization	Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name	Cardiovascular Medicine
Address	2-5-1 Shikada-cho Kita-ku Okayama
TEL	086-235-7351
Homepage URL
Email	miyoshit@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences, Department of Cardiovascular Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011756