Evaluation of Add-on Therapy with Bempedoic Acid and Ezetimibe Fixed Dose Combination versus Add-on Atorvastatin on LDL Cholesterol Levels in Patients with Uncontrolled LDL Cholesterol on Atorvastatin 40 mg: A 12-week Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Change in LDL-C levels from baseline to 12 weeks in both treatment groups
研究概览
简要总结
This 12-week randomized controlled trial aims to evaluate the efficacy and safety of a fixed-dose combination of bempedoic acid (180 mg) and ezetimibe (10 mg) compared to atorvastatin 40 mg in patients with uncontrolled LDL cholesterol (LDL-C) despite being on atorvastatin therapy. The study focuses on patients aged 18-80 years who have LDL-C levels ≥100 mg/dL, despite being on atorvastatin 40 mg for at least 6 weeks. The primary hypothesis is that the combination therapy of bempedoic acid and ezetimibe will not be inferior to atorvastatin 40 mg in reducing LDL-C levels.
The trial includes two groups: one receiving the combination of bempedoic acid and ezetimibe with a placebo for atorvastatin, and the other receiving atorvastatin 40 mg with a placebo for the combination therapy. Both groups will be treated for 12 weeks, with follow-up visits at 4 and 12 weeks to monitor LDL-C levels, other lipid parameters (such as total cholesterol, non-HDL-C, and triglycerides), and safety outcomes. The study also evaluates the proportion of patients achieving LDL-C levels below 100 mg/dL and compares the safety profiles of both treatments.
Statistical analysis will include ANCOVA to compare LDL-C changes between the two groups, adjusting for baseline LDL-C levels and other relevant factors. Safety and tolerability will be assessed through the incidence of adverse events, laboratory abnormalities, and any serious adverse events. With an estimated sample size of 220 patients, the study aims to provide insights into the potential of the bempedoic acid and ezetimibe combination as a viable alternative for patients who do not achieve sufficient LDL-C control with atorvastatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •On a stable dose of atorvastatin 40 mg for at least 6 weeks before screening LDL-C more than 100 mg/dL at screening, despite being on atorvastatin 40 mg Written informed consent.
排除标准
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the study period severe diabetes and complications (e.g., diabetic ketoacidosis, hyperosmolar nonketotic coma).
- •recent history of major cardiovascular events, transient ischemic attack, unstable or symptomatic cardiac arrhythmia, or history of severe heart failure, uncontrolled hypertension history of gout or elevated uric acid levels fasting blood triglycerides greater than 500 mg/dL at screening significant liver disease, active hepatitis, severe hepatic impairment, or liver failure history of rhabdomyolysis, unexplained muscle pain, weakness, or unexplained creatinine kinase history of tendon rupture recently severe renal impairment use of other lipid-lowering therapies.
结局指标
主要结局
Change in LDL-C levels from baseline to 12 weeks in both treatment groups
时间窗: 0,4,12 weeks
次要结局
- Change in total cholesterol, non-HDL-C, & triglycerides from baseline to 12 weeks(0,4,12 weeks)
- Safety & tolerability outcomes, including:(Incidence of adverse events.)
- percentage of patients achieving LDL-C less than 100 mg/dL at 12 weeks(0,12 weeks)
研究者
Amalkrishnan
All India Institute of Medical Sciences New Delhi