Rosuvastatin + Fenofibrate Tablets in the Management of Patients with Mixed Dyslipidaemia

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: A FDC of Rosuvastatin 10mg + Fenofibrate 160mg: Rosuvastatin 10mg + Fenofibrate 160mg,once daily, Duration 12 weeks Control Intervention1: A FDC of Atorvastatin 10mg + Fenofibrate 160mg: Atorvastatin 10mg + Fenofibrate 160mg,once daily, Duration 12 weeks CONDITION: Mixed Dyslipidaemia PRIMARY OUTCOME: Percentage of subjects who reach LDL‐C goals as per NCEP ATP III guidelines, Percentage of subjects who reach the target goal of HDL‐C > 40mg/dl for men and > 50mg/dl for women, Percentage of patients who reach the target goal of TG <150mg/dl after 12 weeks of study.‐‐‐‐‐‐Timepoint: 0,4,8 & 12 weeks SECONDARY OUTCOME: The Secondary outcome is to evaluate safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study‐‐‐‐‐‐Timepoint: 0,4,8 & 12 weeks INCLUSION CRITERIA: Subjects of both sexes aged between 18‐65 years will be included in the study. Patients lipid results after 10‐12 hour fasting interval including: LDL‐C > 130mg/dl TG >150mg/dl HDL ? C < 40mg / dl for men and < 50 mg / dl for women ?Mixed dyslipidaemia Naive subjects / with or without dietary counselling (OR) ?Subjects receiving treatment with starting dose of other lipid lowering therapies, but who have failed to achieve the LDL‐C goal levels as per NCEP ATP III guidelines
Epistemonikos ID: 368d2fab4b92537018002a153c536e9dcad458e4
First added on: Aug 22, 2024