"A CONTROL LABELED, RANDOMIZED, COMPARATIVE, PARALLEL GROUP, MULTICENTRIC PHASE III STUDY TO EVALUATE THE SAFETY AND EFFICACY FDC OF ROSUVASTATIN CALCIUM 5 mg & FENOFIBRATE 145 mg V/S ROSUVASTATIN 5mg IN PATIENTS SUFFERING WITH MIXED DYSLIPEDEMIA".
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Change from baseline in low density lipoprotein cholesterol after 12 weeks.
研究概览
简要总结
The study will be conducted after obtaining written informed consent from the subjects. The subjects will undergo medical screening during pre-study visit (Visit 1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs), and laboratory tests {Fasting Serum Lipid Profile, Liver function tests (SGOT, SGPT, Serum Bilirubin), Renal Function Tests (Serum Creatinine, and Serum Uric Acid). Blood sample will be collected for laboratory evaluations during screening. Female volunteers of child bearing capability will be subjected to a urine pregnancy test. The subject would be randomized in two parallel arm and according to the randomization done they would be assigned for the treatment for either of the arm FDC of Rosuvastatin and Fenofibrate ,or monotherapy of Rosuvastatin Calcium
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
入选标准
- •Subjects of either sex of age 18 and 70 years.Low-density lipoprotein (LDL)-cholesterol levels > 100 mg/dL, high-density lipoprotein (HDL)-cholesterol levels < 50 mg/dL (for women) and < 40 mg/dl (for men), or triglyceride levels > 150 mg/dL.Willing to give written informed consent.
排除标准
- •Hypersensitivity to either of the formulation components.Severe renal dysfunction.Hepatic dysfunction, including primary biliary cirrhosis and unexplained persistent liver function abnormality.Pre-existing gallbladder disease.xSubjects with a history of known hypersensitivity from any one of the said medication.Pregnant women or lactating woman.Participation in a clinical trial with an investigational agent during the past 30 days.Simultaneous participation in a clinical study.Severe uncontrolled systemic disease.
结局指标
主要结局
Change from baseline in low density lipoprotein cholesterol after 12 weeks.
时间窗: 12 weeks
次要结局
- Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks.Number of patients who reach target LDL after 12 weeks.(12 weeks)