A Randomized, Open Label, Multicentre, Comparative Clinical Trial of IN-SUPR-002 in Comparison with Fixed Dose Combination (FDC) of Fenofibrate and Rosuvastatin in Patients with Mixed Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 14
- 主要终点
- % Change in serum triglycerides
研究概览
简要总结
Around the world, cardiovascular disease (CVD) is the leading cause of deaths for adults. The most important modifiable cardiovascular risk factors are smoking, hypertension, dyslipidemia, obesity and hyperglycemia. These risk factors are often clustered, particularly for patients with type 2 diabetes and/or metabolic syndrome. Among dyslipoproteinemia, mixed or combined hyperlipidemia is a common disorder, occurring in about 30% of myocardial infarction (MI) survivors.
The aim of this study is to evaluate the safety and efficacy of IN-SUPR-002 in comparison with FDC of fenofibrate and rosuvastatin in treatment of patients with mixed dyslipidemia. The study will be carried out in 240 Patients of either sex between 18 and 70 years of age suffering from mixed dyslipidemia enrolled across India.
Both the treatment groups will be compared at the end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Between age of 18 to 70 years
- •Serum triglycerides between 150 mg/dl and 500 mg/dl
- •Serum LDL-C > 100 mg/dl
- •Serum HDL-C < 40 mg/dl for men and < 50 mg/dl for women
- •Willing to give their informed consent.
排除标准
- •Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
- •Patients with type 1 diabetes mellitus.
- •Patients with thyroid dysfunction.
- •Patients with hypersensitivity to rosuvastatin, fenofibric acid or fenofibrate.
- •Patients who are chronic alcoholic (> 20 ml of alcohol/day) 6.
结局指标
主要结局
% Change in serum triglycerides
时间窗: At the end of study as compared to baseline
次要结局
- % Change in LDL-C(% Change in HDL-C)