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

Ranbaxy Laboratories Ltd (India)0 sites360 target enrollmentNovember 6, 2007

Overview

No summary available.

Registry

who.int

Start Date

November 6, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Ranbaxy Laboratories Ltd (India)

•1\. Diabetes type II defined by American Diabetes Association criteria of fasting venous plasma glucose of greater than or equal to 126 mg/dl, two\-hour post prandial plasma glucose of greater than or equal to 200 mg/dl or already on treatment of diabetes
•2\. Dyslipidemia defined by Low Density Lipoprotein (LDL) cholesterol more than 100 mg/dl or on prior statin therapy
•3\. Age of greater than or equal to 30 and less than or equal to 70 years
•4\. Informed consent by the patient

•1\. Failure to give informed consent
•2\. A history of hypersensitivity to statins
•3\. Evidence of fundoscopy grade 2 hypertensive or diabetic retinopathy
•4\. Serum creatinine greater than 1\.5 mg/dl
•5\. Overt proteinuria
•6\. Pregnant or lactating mothers
•7\. Evidence/history of heart failure
•8\. Systolic blood pressure above 180 mmHg and diastolic blood pressure above 110 mmHg
•9\. Recent history of cerebrovascular disease, myocardial infarction, unstable angina, new onset Left Bundle Branch Block (LBBB) in the past 4 weeks
•10\. Documented case of homozygous familial hypercholesterolemia