Health Condition 1: null- Mixed Dyslipidemia
Conditions
Interventions
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
Sponsors
NIL Investigator Initiated Trial
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1) Patients who are already on treatment with statins or fibrates. 2) Patients allergic/hypersensitive to either Atorvastatin or Fenofibrate. 3) Pregnant and Lactating women. 4) Women of child bearing age not using acceptable methods of contraception. 5) Patients with active liver disease having elevated liver enzymes. 6) Patients with Uncontrolled Diabetes Mellitus with FBS >200mg/dL even after therapy with OHA/Insulin. 7) Patients with elevated Creatine Kinase levels /muscular disorders. 8) Post-MI, Post-CABG, Post-PTCA, Post-Stroke patients within six months of occurrence of the event. 9) CCF patients receiving Digoxin. 10) Patients unwilling to give informed consent. 11) Mentally challenged patients who are unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in TGL and non-HDL levels from baseline to 12weeks of therapy.Timepoint: 0, 6weeks, 12weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDR. N. HARIVENKATESH
SRI RAMACHANDRA UNIVERSITY
Outcome results
None listed