NIPH Clinical Trials Search

UMIN ID: UMIN000002202

Registered date:01/08/2009

Effect of Ezetimibe on Serum Remnant-Like Particle (RLP) Cholesterol in dyslipidemic patients with Diabetes Mellitus or the Metabolic Syndrome (EZREC Study)

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedHypercholesterolemia, Dyslipidemia
Date of first enrollment2009/09/01
Target sample size170
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Ezetimibe (10mg) daily, for 12 weeks Diet therapy, for 12 weeks


Primary OutcomePercent change of the serum levels of RLP- Cholesterol
Secondary OutcomePercent change of the serum levels of following parameters: total cholesterol (T-C), triglyceride, HDL-C, LDL-C, non-HDL-C, Apolipoproteins (A-I, A-II, B, C-II, C-III, E), ApoB/ApoA-I, small dense LDL, total adiponectin, high-sensitivity CRP, oxidized LDL, soluble LOX-1, Lp-PLA2, homocystein 2) Adverse Events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1. Patients who had ischemic heart diseases 2. Patients who had stroke within the past 12 weeks 3. TG => 400 mg/dL 4. Familial Hypercholesterolemia 5. Patients with insulin treatment 6. Serious liver or renal diseases 7. Serious pulmonary disorder, and uncontrollable heart failure or arrhythmia 8. Patients who had taken probcol within the past 8 weeks 9. Patients who had been prescribed any other anti-hypercholesterol drugs within the past 4 weeks 10. Secondary dyslipidemia and drug induced dyslipidemia 11. Alcoholism, drug abuse or severe mental disorders 12. Patients who had severe anaphylactic reaction to ezetimibe or any other drug 13. During pregnancy or lactation 14. Other conditions precluding participation as judged by the investigator

Related Information


public contact
Name Manabu MINAMI, MD, PhD
Address 54 Kawahara-cho, Shogoin, Sakyo-ku Kyoto 606-8507, Japan Japan
Telephone 075-751-4739
Affiliation Kyoto University Hospital Translational Research Center
scientific contact
Name Masayuki YOKODE, MD, PhD
Address 54 Kawahara-cho, Shogoin, Sakyo-ku Kyoto 606-8507, Japan Japan
Telephone 075-751-4743
Affiliation Graduate School of Medicine, Kyoto University Department of Clinical Innovative Medicine