Effect of Fenofibrate and Ezetimibe Combination Treatment on Lipid

UMIN ID: UMIN000001224

Registered date:01/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type IIb Dyslipidaemia
• Date of first enrollment: 2008/07/01
• Target sample size: 280
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Fenofibrate(200mg)+Ezetimibe(10mg)group 52 weeks
Fenofibrate(200mg) group 52 weeks
Ezetimibe(10mg) group 52 weeks

Outcome(s)

• Primary Outcome: Per cent change in LDL-C from baseline Per cent change in TG from baseline
• Secondary Outcome: Incidence rate (AE) Per cent change in HDL-C from baseline

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: Main criteria for exclusion: Wash Out period;-8 weeks 1)Patients who have received probucol in the past 1 year 2)Patients with familial hypercholesterolemia 3)Patients with hyperlipidaemia caused by steroid hormone 4)Patients who have a clinical relevant history or presence as follows malignant neoplasm, thyroid disease, HbA1c>8%, pancreatitis, active liver disease(AST or ALT>200% of UNL or 80IL), Creatinine>1.5mg/dL, gallstone, gallbladder, drugs or alcohol abuse, after patient must no have coronary heart disease and Cerebral Vascular Accident in the past 3 months, uncontrolled arrhythmia 5)History of significant sensitivity to any drug, including fenofibrate and ezetimibe 6)Patients who cannot discontinue the contraindicated medications 7)Pregnant or breast-feeding female 8)Considered by the investigator, for any reason, to be unsuitable candidate for receiving fenofibrate or ezetimibe 9) Patients who have an excellent physical condition under present treatment 10) Patients who are otherwise judged inappropriate for inclusion in the study by the investigators

Related Information

• Primary Sponsor: Comprehensive Support Project for Life-style related disease (CSP-LD)
• Source(s) of Monetary Support: Aska Pharmaceutical Co.,Ltd.