hypercholesterolemia
Conditions
Interventions
experimental group:Xuezhikang 1200mg orally once daily
control group:Xuezhikang 600mg orally twice daily
Sponsors
The First Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Eligible subjects aged >=18 years, men or women; (2) The low-density lipoprotein cholesterol (LDL-C) was >= 3.0 mmol/L (116 mg/dL), but = 18.5 kg/m^2 but < 30 kg/m^2; (4) Female patients must be postmenopausal, that is, at least 12 months after menopause, or sterilized at least 3 months before the study begins, or have a negative pregnancy test and agree to use reliable contraceptive methods during the study period until one month after the study ends; (5) Patients must be willing to follow a therapeutic lifestyle changes diet (TLC diet); (6) Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion criteria
Exclusion criteria: (1) History of ASCVD including previous ACS (MI or unstable angina), stable angina, coronary revascularization (PCI, CABG, and other arterial revascularization procedures), stroke and TIA or peripheral arterial disease; (2) Uncontrol hypertension at screening visit(consulting room systolic blood pressure >= 180mmHg, diastolic blood pressure >= 110mmHg); (3) Patients with certain liver dysfunction or elevations of serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 1.5 times the upper limit of normal (ULN); (4) Patients with elevations of creatine kinase (CK) to above the ULN; (5) Patients with certain renal dysfunction or elevated serum creatinine levels beyond the range of ULN; (6) Diabetes mellitus (DM) patients except those young patients (T1DM <35 years; T2DM <50 years) with DM duration <10 years and without other risk factors; (7) Other endocrine diseases that might influence the levels of lipid and lipoprotein such as hypothyroidism, or nephrotic syndrome; (8)Allergy to xuezhikang; (9) Patients received another research drug within 4 weeks prior to the screening visit; (10) Other situations that may prevent the patient from participating in the study (e.g., active psychosis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean percentage changes from baseline to week 8 in serum low-density lipoprotein cholesterol (LDL-C); | — |
Secondary
| Measure | Time frame |
|---|---|
| mean percentage changes from baseline to week 8 in total cholesterol (TC);mean percentage changes from baseline to week 8 in serum high-density lipoprotein cholesterol (HDL-C);mean percentage changes from baseline to week 8 in serum triglycerides (TG);mean percentage changes from baseline to week 8 in serum non-high-density cholesterol (non-HDL-C);mean percentage changes from baseline to week 8 in the ratio of Apo A-I to Apo-B;mean percentage of LDL-C lower than 2.6 mmol/L (100 mg/dL) at the end of week 8;Assessment of compliance;mean percentage changes from baseline to week 8 in Apo B;mean percentage changes from baseline to week 8 in Apo A-I;mean percentage changes from baseline to week 8 in Lp(a);Proportion of patients reaching LDL-C target of <3.0 mmol/L (116 mg/dL) at week 8;Proportion of patients reaching LDL-C target of <1.8 mmol/L (70 mg/dL) at week 8; | — |
Countries
China
Contacts
Public ContactYugang Dong
The First Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed