Type IIb Dyslipidaemia
Conditions
Interventions
Fenofibrate(200mg)+Ezetimibe(10mg)group 52 weeks
Fenofibrate(200mg) group 52 weeks
Ezetimibe(10mg) group 52 weeks
Sponsors
Comprehensive Support Project for Life-style related disease (CSP-LD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main criteria for inclusion: Wash Out period;-4 weeks 1)Subjects who are able to give written informed consent 2)Male and female, and age is over 20 years 3)Patients with combined hyperlipidaemia ;400>TG>200mg/dL and LDL-C>140mg/dL
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Per cent change in LDL-C from baseline Per cent change in TG from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate (AE) Per cent change in HDL-C from baseline | — |
Countries
Japan
Contacts
Public ContactStudy support centre Study support centre
Public Health Research Foundation Lifestyle-related disease clinical study support office
Outcome results
None listed