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 Limited0 个研究点目标入组 227 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 已完成
发起方: Hetero Labs Limited
入组人数: 227

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

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/dl
•TG >150mg/dl
•HDL ? 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

研究者

发起方

Hetero Labs Limited

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