Hyperlipidemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) male or female aged 18 to 75 years old; (2) TG 2.3 to 6.5mmol/l; (3) Subjects maintained a consistent low-fat diet throughout the trial period; (4) Women of childbearing age were negative for the urine pregnancy test within 48 hours before the actual treatment, ensuring effective contraceptive measures during the trial; (5) To be willing to sign informed consent.
Exclusion criteria
Exclusion criteria: (1) TC >=7.0 mmol/l; (2) lactating women during pregnancy and women of childbearing age who do not take reliable contraceptive measures; (3) BMI >= 30kg/m2 when randomly enrolled; (4) History of chronic liver disease: AST or ALT is greater than 2 times the upper limit of normal; (5) Chronic kidney disease or nephrotic syndrome: serum creatinine >=179 umol/L; (6) Uncontrolled or untreated hypertension (systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg); (7) known type 1 diabetes, poorly controlled type 2 diabetes (fasting blood glucose >=10.0 mmol/L); (8) Patients who use heparin, thyroid treatment drugs and other drugs that affect blood lipid metabolism, and patients who have used other Chinese and Western medicines to lower blood lipids in the past 2 weeks; (9) long-term systemic use of glucocorticoid therapy; (10) Those who have a history of drug allergy and allergies. (11) severe arrhythmia that cannot be controlled; (12) myocardial infarction, acute coronary syndrome, coronary artery bypass surgery or angioplasty within 6 months prior to enrollment; (13) There are unstable or severe peripheral vascular diseases within the first 3 months after enrollment; (14) People with mental illness and drug dependence; (15) People known to be infected with HIV; (16) Oral contraceptives; women receive hormone therapy, including hormone replacement therapy, any estrogen antagonist/agonist treatment, and the dose is not stable in the first month before the random dose or the dose needs to be changed throughout the trial; (17) Other diseases that limit clinical research assessment or affect the completion of the study (except for hyperlipidemia); (18) Participated in other clinical trials within 3 months prior to the election; (19) The difference between the screening period and the baseline TG measurement value is greater than 20%, and is measured again after one week. The difference between the two TG measurements is still greater than 20%; (20) Cannot accept diet controllers (21) Those who are allergic to fenofibrate; (22) Other circumstances that the investigator considers inappropriate for inclusion or influence on the subject's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Triglyceride; | — |
Countries
China
Contacts
the First Affiliated Hospital of Zhejiang University School of Medicine