Hypercholesterolemia (Adult patients with hypercholesterolemia who meet the criteria for intensive lipid-lowering therapy with Atorvastatin 40 mg/day.) Hypercholesterolemia, Atorvastatin, Generic Atorvastatin, Branded Atorvastatin, Lipid-lowering Effect, Non-inferiority Trial, LDL-C Reduction, Cost-effectiveness
Conditions
Interventions
Participants will receive a generic atorvastatin (CHLOVAS-ZIS 40) at a dose of 40 mg orally once daily for 12 weeks.,Participants will receive a branded atorvastatin (XARATOR 40) at a dose of 40 mg or
Experimental Drug,Active Comparator Drug
Generic Atorvastatin (CHLOVAS-ZIS),Branded Atorvastatin (XARATOR)
Sponsors
Millimed BFS Co., Ltd.
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Adults aged is greater than or equal to 20 years who are currently treated with low-to-moderate intensity statins but have not achieved their LDL-C targets as recommended by the 2024 RCPT Clinical Practice Guideline on Management of Dyslipidemia for Atherosclerotic Cardiovascular Disease Prevention. 2) Adults aged is greater than or equal to 20 years who are statin-never but have preexisting cardiovascular disease or a high risk for atherosclerotic cardiovascular disease (defined as adults aged is greater than or equal to 40 years with diabetes and is greater than or equal to 2 atherosclerotic cardiovascular disease risk factors, adults aged is greater than or equal to 40 years with diabetes and LDL-C > 190 mg/dL, or adults with familial hypercholesterolemia).
Exclusion criteria
Exclusion criteria: 1) Cardiovascular Conditions 1.1 Unstable angina. 1.2 New-onset myocardial infarction within the past 6 months. 1.3 Uncontrolled hypertension (resting SBP is greater than or equal to160 mmHg or DBP is greater than or equal to100 mmHg with antihypertensive agents) 2)Endocrine and Metabolic Disorders 2.1 Poorly controlled diabetes (Glycosylated hemoglobin (HbA1c) is greater than or equal to11 percent or fasting plasma glucose is greater than or equal to 300 mg/dL). 2.2 Elevated serum triglyceride (TG)is greater than or equal to 500 mg/dL 2.3 Uncontrolled hypothyroidism 3) Drug-Related Safety Concerns 3.1 History of hypersensitivity to HMG-CoA reductase inhibitors (statins). 3.2 Use of strong CYP3A4 inhibitors/inducers (e.g., clarithromycin, ketoconazole, HIV protease inhibitors). 3.3 Serum creatinine > 2.5 mg/dL. 3.4 Chronic liver disease. 3.5 Alanine aminotransferase (ALT) more than 3 time the upper limit of normal (ULN). 3.6 Aspartate aminotransferase (AST) > 3 time ULN. 3.7 Creatine kinase (CK) > 3 time ULN. 4) Medical and Psychiatric History 4.1 History of malignancy or psychosis. 4.2 Current or past substance or alcohol abuse. 5) Reproductive Health 5.1 Pregnant or breastfeeding women. 5.2 Women of childbearing potential who are not using adequate contraception. 5.3 Current use of cyclical hormonal contraceptives. 5.4 Intermittent use of hormone replacement therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change of Low-Density Lipoprotein Cholesterol (LDL-C) from baseline to week 12 Baseline, Week 12 (3 months) The difference in percentage change of LDL-C from baseline to week 12 between the generic atorvastatin (CHLOVAS-ZIS 40) and branded atorvastatin (XARATOR 40) groups to determine non-inferiority. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change of other lipid parameters (HDL-C, TGs, and Total Cholesterol) Baseline, Week 12 (3 months) Comparison of the percentage change of high-density lipoprotein cholesterol (HDL-C), TGs, and total cholesterol from baseline to week 12 between generic and branded atorvastatin groups.,Percentage change of glycemic parameters (FBS and HbA1C) Baseline, Week 12 (3 months) Comparison of the percentage change of fasting blood sugar (FBS) and Hemoglobin A1C (HbA1C) from baseline to week 12 between generic and branded atorvastatin groups.,Changes in hematologic parameters, organ functions, CK, TSH, urinalysis, and body composition Baseline, Week 12 (3 months) Comparison of the changes in hematologic parameters, renal function markers, liver function , CK, TSH, urinalysis , body composition measurements from between generic and branded atorvastatin groups.,Quality-Adjusted Life Years (QALY) Week 12 Comparison of the difference of mean quality-adjusted life years (QALY) at 12 weeks between generic and branded atorvastatin groups.,Cost per 1% reduction in LDL-C and Incremental Cost-Effectiveness Ratio (ICER) Week 12 Cost-effectiveness analysis using clinical outcomes and direct medical costs., Incidence of clinical and laboratory adverse events Throughout the 12-week study period ALT/AST more than 3 time ULN, CK more than 10 time ULN, incidence of rhabdomyolysis, adverse event, medications held due to side effects.,Medication Compliance Rate Week 12 Compliance/Adherence: pill count, %compliance greater than or equal to 80 % | — |
Countries
Thailand
Contacts
Public ContactMattabhorn Phornphutkul
Faculty of medicine, Chiang Mai University
Outcome results
None listed