A clinical trial to study the effects of Daily Vs Alternate day therapy with Atorvastatin and Fenofibrate combination in the treatment of Mixed Dyslipidemia.
- Conditions
- Health Condition 1: null- Mixed Dyslipidemia
- Registration Number
- CTRI/2010/091/001328
- Lead Sponsor
- IL Investigator Initiated Trial
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change in TGL and non-HDL levels from baseline to 12weeks of therapy.Timepoint: 0, 6weeks, 12weeks
- Secondary Outcome Measures
Name Time Method 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