Prospective, randomized, open-label, clinical trial comparing fibrate monotherapy and fibrate-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, and markers for anti-inflammatory properties/obesity/antioxidative properties

Prospective, randomized, open-label, clinical trial comparing fibrate monotherapy and fibrate-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, and markers for anti-inflammatory properties/obesity/antioxidative properties - Prospective, randomized, open-label, clinical trial comparing fibrate monotherapy and fibrate-ezetimibe combination therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002964

Enrollment

Registered

2010-01-03

Start date

2010-01-01

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

dyslipidemia

Interventions

Administration of ezetimibe No medication

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Dyslipidemic patients under treatment with fibrates, whose LDL-C levels do not meet those recommended by Japan Atherosclerosis Society Guidelines for prevention of Atherosclerotic Cardiovascular Disease. 2) Patients who have aortic atherosclerotic plaques detected by MRI 3) Outpatients 4) Subjects who gave written informed consent

Exclusion criteria

Exclusion criteria: 1) Allergy against ezetimibe 2) Under treatment with statins 3) Poor-controlled hypertension (DBP>110 mmHg) 4) Poor-controlled diabetes (HbA1c>10.0 %) 5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 6) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 7) Chronic renal failure (serum creatinine>2.0 mg/dl) 8) Malignancies or other diseases with poor prognosis 9) Pregnant 10) Subjects whose doctor in charge do not agree to join the trial

Design outcomes

Primary

Measure	Time frame
Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6/12/24 months after randomization Flow-mediated vasodilation in forearm, 6 months after randomization Heparin-releasable EC-SOD levels, 6 months after randomization	—

Secondary

Measure	Time frame
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6/12/24 months after randomization	—

Countries

Japan

Contacts

Public ContactMakoto Ayaori

National Defense Medical College Department of Internal Medicine I

ayaori@ndmc.ac.jp04-2995-1597

Outcome results

None listed

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