A clinical trial to study the effects of Daily Vs Alternate day therapy with Atorvastatin and Fenofibrate combination in the treatment of Mixed Dyslipidemia

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: Fixed Dose Combination of Atorvastatin 10mg & Fenofibrate 160mg: One Tablet to be taken at night on ALTERNATE DAYS for 12 Weeks Control Intervention1: Fixed Dose Combination of Atorvastatin 10mg & Fenofibrate 160mg: One Tablet to be taken at night DAILY for 12 Weeks CONDITION: Mixed Dyslipidemia PRIMARY OUTCOME: Percent change in TGL and non‐HDL levels from baseline to 12weeks of therapy.‐‐‐‐‐‐Timepoint: 0, 6weeks, 12weeks SECONDARY OUTCOME: 1) Percent change in Total Cholesterol, HDL, VLDL, LDL Cholesterol, TC/HDL ratio and TGL/HDL ratio from baseline to 12weeks of therapy. 2)Incidence of Adverse events in both groups and Percent change in SGOT, SGPT from baseline to 12weeks of therapy. 3)Pharmacoeconomic evaluation in both groups.‐‐‐‐‐‐Timepoint: 0, 6weeks, 12weeks INCLUSION CRITERIA: 1) Adult Male and Female patients of age >18years and <= 65years who are diagnosed as Mixed Dyslipidemia and meet the criteria for pharmacological treatment as per updated NCEP‐ATP III guidelines 2) Fasting LDL levels >= 130mg/dL, Fasting TGL levels >= 200mg/dL, Fasting Total Cholesterol levels >= 200mg/dL 3) Patients who failed to achieve lipid target goals as per updated NCEP‐ATP III guidelines with Therapeutic life style changes or with other modalities of treatment 4) Eligible patients who are willing to participate in the study by voluntarily signing the Informed Consent Form
Epistemonikos ID: 6ece9fa85b7460495a211098db0bb2d80e40c67b
First added on: Aug 22, 2024