A Randomized Controlled Trial to evaluate the Efficacy and Safety of Alternate day therapy with Atorvastatin and Fenofibrate combination in the treatment of Mixed Dyslipidemia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Percent change in TGL and non-HDL levels from baseline to 12weeks of therapy.
研究概览
简要总结
This is a Randomized, open labeled, parallel group, single centre study to evaluate the efficacy and safety of Alternate day therapy with Atorvastatin and Fenofibrate combination in comparison with Daily therapy in the treatment of Mixed Dyslipidemia. 110 patients diagnosed with Mixed Dyslipidemia requiring pharmacological treatment as per Updated NCEP-ATP III guidelines will be enrolled in the study. (55 study participants in each group). Only the patients satisfying the eligibility criteria and willing to participate in the study by voluntarily signing the informed consent form will be included in the study. The study drug is Fixed Dose Combination of Atorvastatin 10mg and Fenofibrate 160mg.The participants in the interventional group will receive the study drug on Alternate days for 12weeks. The study participants in the control group will receive the study drug daily for 12weeks. The primary endpoint is the percent change in TGL and non-HDL levels from baseline to 12weeks of therapy. The secondary endpoints are Percent change in Total Cholesterol, HDL, VLDL, LDL Cholesterol, TC/HDL ratio and TGL/HDL ratio from baseline to 12weeks of therapy, Pharmacoeconomic evaluation in both groups. The safety endpoints are Incidence of Adverse events in both groups and Percent change in SGOT, SGPT from baseline to 12weeks of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •Adult Male and Female patients of age >18years and <= 65years who are diagnosed as Mixed Dyslipidemia and meet the criteria for pharmacological treatment as per updated NCEP-ATP III guidelines 2) Fasting LDL levels >= 130mg/dL, Fasting TGL levels >= 200mg/dL, Fasting Total Cholesterol levels >= 200mg/dL 3) Patients who failed to achieve lipid target goals as per updated NCEP-ATP III guidelines with Therapeutic life style changes or with other modalities of treatment 4) Eligible patients who are willing to participate in the study by voluntarily signing the Informed Consent Form.
排除标准
- •Patients who are already on treatment with statins or fibrates.
- •Patients allergic/hypersensitive to either Atorvastatin or Fenofibrate.
- •Pregnant and Lactating women.
- •Women of child bearing age not using acceptable methods of contraception.
- •Patients with active liver disease having elevated liver enzymes.
- •Patients with Uncontrolled Diabetes Mellitus with FBS>200mg/dL even after therapy with OHA/Insulin.
- •Post-MI, Post-CABG, Post-PTCA, Post-Stroke patients within six months of occurrence of the event.
- •CCF patients receiving Digoxin.
- •Patients unwilling to give informed consent.
结局指标
主要结局
Percent change in TGL and non-HDL levels from baseline to 12weeks of therapy.
时间窗: 0, 6weeks, 12weeks
次要结局
- 1) Percent change in Total Cholesterol, HDL, VLDL, LDL Cholesterol, TC/HDL ratio and TGL/HDL ratio from baseline to 12weeks of therapy. 2)Incidence of Adverse events in both groups and Percent change in SGOT, SGPT from baseline to 12weeks of therapy. 3)Pharmacoeconomic evaluation in both groups.(0, 6weeks, 12weeks)