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

UMIN ID: UMIN000002202

Registered date:01/08/2009

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Hypercholesterolemia, Dyslipidemia
• Date of first enrollment: 2009/09/01
• Target sample size: 170
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ezetimibe (10mg) daily, for 12 weeks
Diet therapy, for 12 weeks

Outcome(s)

• Primary Outcome: Percent change of the serum levels of RLP- Cholesterol
• Secondary Outcome: Percent 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 minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. 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

• Primary Sponsor: Graduate School of Medicine, Kyoto University
• Source(s) of Monetary Support: None