A clinical trial to study the effects of two drugs, Fixed dose combination of tablets of Rosuvastatin 5 mg and Fenofibrate 160mg with Rosuvastatin 5mg alone in patients with dyslipidemia

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: FDC of Rosuvastatin and Fenofibrate: 5mg and 160 mg, once daily Control Intervention1: Rosuvastatin: 5mg , once daily CONDITION: Dyslipidemia PRIMARY OUTCOME: change from baseline values of LDL‐C, serum triglycerides, HDL‐C‐‐‐‐‐‐Timepoint: 12 weeks SECONDARY OUTCOME: Achievement of target levels of total cholesterolnd LDL cholesterol, patient compliance‐‐‐‐‐‐Timepoint: INCLUSION CRITERIA: Male and female outpatients between 18‐75 tears of age. Patients having i. LDL cholesterol>130mg/dl ,ii.Serum triglycerides > or equal to 150mg/dl and < or equal to 500mg/dl. Able to stop current statin therapy without risk to the patient Patients who are able to adequately maintain diary. Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved ICF
Epistemonikos ID: 945ddb9653296e1d21f022225335469c6de5ca89
First added on: Aug 22, 2024