An Open-Label, Prospective, Non-Comparative Clinical Trial To Evaluate The Efficacy And Safety of Rosuvastatin In High Risk Indian Population With Diabetes and Dyslipidemia by evaluating the efficacy of Rosuvastatin in changing the Total Cholesterol, Low Density Lipoprotein, High Denisty Lipoprotein, and Triglycerides in Diabetic patients who have altered lipid levels (Dyslipidemia)

Ranbaxy Laboratories Ltd0 个研究点目标入组 360 人开始时间: 2007年9月21日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Diabetes Type II defined by American Diabetes Association (ADA) criteria of fasting venous plasma glucose of = 126 mg/dl, 2 hour post prandial plasma glucose of = 200 mg/dl or already on treatment of diabetes.
•Dyslipidemia defined by LDL Cholesterol more than 100 mg/dl or on prior statin therapy.
•Age of = 30 and = 70 years
•Informed consent by the patient.

•Failure to give informed consent
•A history of hypersensitivity to statins
•Evidence of Fundoscopy grade 2 hypertensive or diabetic retinopathy
•Serum creatinine > 1.5 mg/dl
•Overt Proteinuria
•Pregnant or lactating mothers
•Evidence / History of Heart Failure
•Systolic Blood Pressure above 180 mmHg and Diastolic Blood Pressure above 110 mmHg
•Recent history of Cerebrovascular disease, myocardial infarction, unstable angina, new onset LBBB in the past 4 weeks
•Documented case of homozygous familial hypercholesterolemia
•Type I Diabetes Mellitus
•Use of concomitant medications (cyclosporine, systemic itraconazole or ketoconazole, erythromycin, or clarithromycin, glucocorticoids or verapamil) known to affect the lipid profile or with potency safety concernRecent ongoing inter current infection / hs CRP > 10 mg/L
•Active liver disease or hepatic dysfunction (defined as alanine aminotransferase (ALT), aspartate aminotransferase, alkaline phosphate or bilirubin levels = 1.5 the upper limit of normal
•Diagnosed to have any other endocrinal or metabolic disease other than Type II DM that is known to influence serum lipids and lipoproteins
•Patients having history suggestive of myalgia / myositis / arthralgia
•Serious or unstable medical or psychological condition that could compromise the patient’s safety or successful trial participation
•History of alcohol consumption > 2 drinks/day (30 ml) or 10 drinks per week

发起方

Ranbaxy Laboratories Ltd