ACTRN12607000473460
Recruiting
Not Applicable
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 sites360 target enrollmentSeptember 21, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dyslipidemia in patients with Diabetes Mellitus
- Sponsor
- Ranbaxy Laboratories Ltd
- Enrollment
- 360
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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