Open-labeled randomized parallel trial to compare the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of standard atorvastatin administration.

Open-labeled randomized parallel trial to compare the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of standard atorvastatin administration. - Comparison of the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of atorvastatin administration.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002698

Enrollment

120

Registered

2009-11-02

Start date

2009-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease

Interventions

Patients who have more than 100mg/dL of LDL-C in spite of taking atorvastatin 10mg/day will be additionally administered another 10mg/day of atorvastatin for 6 months. Patients who have more than 100m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who have a history of myocardial infarction or angina pectoris diagnosed by coronary angiography, or have more than 25% stenosis in coronary artery assessed by MDCT. 2) Patients who meet a criteria for metabolic syndrome (NCEP-ATP3 2004 with some modifications) 3) Patients who have more than 100mg/dL of LDL-C in spite of taking atorvastatin 10mg/day for at least 3 month.

Exclusion criteria

Exclusion criteria: 1) Patients with more than 500mg/dL of triglyceride. 2) Patients with hepatic dysfunction [ALT>3 x upper limit of normal range.] 3) Patients with renal dysfunction [Serum creatinine >2 x upper limit of normal range] 4) Patients with a history of myocardial infarction, unstable angina, CABG operation or stroke within recent 3 months. 5) Patients with uncontrolled diabetes mellitus (HbA1c>9%). 6) Patients with a history of drug-allergy (shock, anaphylaxis, vascular edema). 7) Patients taking immune-suppressor. 8) Patients with familial hypercholesterolemia. 9) Patients with secondary hyperlipidemia. 10) Alcohol abusers. 11) Patients with drug-induced hyperlipidemia (steroid, or other medicine) 12) Pregnant or possibly pregnant women. Those who want or are wanted by the partner to be pregnant. 13) Patients hypersensitive with this medicine and /or contaminants of this medicine. 14) Patients who are judged to be inappropriate as a subject by a doctor.

Design outcomes

Primary

Measure	Time frame
Change of LDL-C	—

Secondary

Measure	Time frame
1) Changes of RLP-C, hs-CRP, lipid peroxidation, Non HDL-C, Non HDL-C/HDL-C, LDL-C/HDL-C, TC, TG, HDL-C. 2) Change of insulin resistance.	—

Countries

Japan

Contacts

Public ContactMorihiro Matsuda

National Hospital Organization, Kure Medical Center and Chugoku Cancer Center Department of Cardiology

morihiro-m@kure-nh.go.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026