ESSENS-HYPERLIPIDEMIA TRIAL

STUDY POPULATION
  • INCLUSION CRITERIA
  • Male or Female aged ≥ 18 years to ≤ 65 years
  • New Diagnosed:
    Newly diagnosed hyperlipidemia with Low Density Lipoprotein Cholesterol (LDL-C) levels >120 mg/dL
  • Statin naïve*:
    Patients who have never been on statins or any other lipid lowering therapy
  • Informed consent:
    Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures.
  • EXCLUSION CRITERIA
  • Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
  • Impaired renal function as shown by but not limited to Serum Creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female
  • Uncotrolled blood pressure > 150 mmhg systolic and > 100mmhg diastolic
  • Clinical evidence of active liver disease or serum alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)
  • Pregnancy or lactating women
  • Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

*In addition, a separate small group of participants who are already on Atorvastatin 10 mg daily treatment with life stylemodification program for at least 03 months and continue tohave LDL‐C >120 mg/dl will also be recruited.