Study to evaluate the efficacy and safety of rosuvastatin in indian population who have diabetes with abnormal lipid levels (dyslipidemia)

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)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000473460

Acronym

RESIDD

Enrollment

360

Registered

2007-09-21

Start date

2007-09-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Rosuvastatin 10 mg once a day for first 6 weeks and if the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) guideline of Low Density Lipoprotein - Cholesterol (LDL-C) of less than 100 mg/dl is not achieved then the dose will be increased to 20 mg once a day for another 6 weeks

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Healthy volunteers

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 • 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

Outcome results