Comparative, Randomised, Double Blind, Parallel, Multicentric Study of Efficacy and Safety of Rosuvastatin + Fenofibrate Fixed Dose Combination Versus Atorvastatin + Fenofibrate Fixed Dose Combination in the Management of Patients with Mixed Dyslipidaemia.

Hetero Labs Limited11 个研究点分布在 1 个国家目标入组 227 人开始时间: 待定

试验速览

阶段: 3 期
发起方: Hetero Labs Limited
入组人数: 227
试验地点: 11
主要终点: Percentage of subjects who reach LDL-C goals as per NCEP ATP III guidelines, Percentage of subjects who reach the target goal of HDL-C > 40mg/dl for men and > 50mg/dl for women, Percentage of patients who reach the target goal of TG <150mg/dl after 12 weeks of study.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a Comparative, Randomized, Double blind, Parallel, Multicentric study for Efficacy and Safety of Rosuvastatin+ Fenofibrate versus Atorvastatin + Fenofibrate in the Management of Patients with Mixed Dyslipidaemia. 2. The proposed number of subject to be enrolled in to the study is 300 (this number includes the Screening) and data will be submitted 200 completed patients. Study population will comprise of Patients with Mixed Dyslipidaemia. 3. The recommended dose of Rosuvastatin in dose of 10mg + Fenofibrate in dose of 160mg in comparison with Atorvastatin in the dose of 10mg + Fenofibrate in dose of 160mg once daily for 12 weeks. 4. The primary efficacy outcome will be Percentage of subjects who reach LDL-C goals as per NCEP ATP III guidelines, Percentage of subjects who reach the target goal of HDL-C > 40mg/dl for men and > 50mg/dl for women, Percentage of patients who reach the target goal of TG <150mg/dl after 12 weeks of study and the secondary efficacy outcome is to evaluate of the safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study.

研究设计

分配方式: Computer generated randomization
盲法: Participant, Investigator and Outcome Assessor Blinded

入排标准

入选标准

•Subjects of both sexes aged between 18-65 years will be included in the study.Patients lipid results after 10-12 hour fasting interval including:LDL-C > 130mg/dlTG >150mg/dlHDL ?
•C < 40mg / dl for men and < 50 mg / dl for women ?Mixed dyslipidaemia Naive subjects / with or without dietary counselling (OR)?Subjects receiving treatment with starting dose of other lipid lowering therapies, but who have failed to achieve the LDL-C goal levels as per NCEP ATP III guidelines.

排除标准

•?Patients unwilling or unable to give informed consent?Patients with secondary hypercholesterolemia, known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoprotenaemia)?Patients with uncontrolled diabetes (i.e. fasting blood sugar > 140 mg/dl), nephrotic syndrome, myeloma, obstructive liver disease, hypothyroidism, alcoholism?Patients with clinically significant gastrointestinal, respiratory, hepatic, renal or haematological disorder or any other severe concurrent illness, major surgery or acute infection, gram negative sepsis, extensive burns or cancer within past 5 years ?Patients with unstable angina, severe heart failure, cardiac arrhythmias, myocardial infarction, coronary artery bypass surgery, coronary angioplasty within three months prior to inclusion in the study.?Patients with suspected bilateral renal artery stenosis, single kidney.?Patients with active liver disease or hepatic dysfunction as defined by elevations of SGOT or SGPT > 1.5 times the ULN, alkaline Phosphatase or total serum bilirubin > 1.2 times ULN, serum creatinine >1.2 mg/dl or creatinine phosphokinase 1.5 times ULN?Patients requiring treatment with potent CYP3A4 inhibitors like cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin?Patients who had experienced unexplained muscle pain, tenderness or weakness with any other medication of statin group previously?Pregnant women, women who are breast feeding, and women of childbearing potential not using medically accepted methods of contraception?Participation in another investigational drug trial within the previous 4 weeks?Subjects randomised to treatment who subsequently withdraw cannot re-enter this trial?Subjects with serious or unstable medical or psychological condition that in the opinion of the investigator would compromise the subject?s safety or successful participation in the trial.?NACP target reach.

结局指标

主要结局

Percentage of subjects who reach LDL-C goals as per NCEP ATP III guidelines, Percentage of subjects who reach the target goal of HDL-C > 40mg/dl for men and > 50mg/dl for women, Percentage of patients who reach the target goal of TG <150mg/dl after 12 weeks of study.

时间窗: 0,4,8 & 12 weeks

次要结局

The Secondary outcome is to evaluate safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study(0,4,8 & 12 weeks)

研究者

发起方

Hetero Labs Limited

研究点 (11)

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