ESSENS-HYPERLIPIDEMIA TRIAL

PATIENT VISIT SCHEDULE
Evaluation Visit 01/ Baseline Visit 02/ Randomization Day 02 + 02 days Visit 03/Week 04± 04 days Visit 04/ ET Week 12± 04 days
Inclusion/Exclusion Criteria x x    
Informed consent x      
Demographic Details x      
Clinical Evaluation/
Physical Examination and Vital sign
 x x x x
Electrocardiogram   x   x
Laboratory Assessment x   x x
IP Dispensing   x x  
IP Accountability     x x
Compliance Assessment     x x
Concomitant medication x x x x
Life style modification program x x x x
LABORATORY PARAMETER SCHEDULE
Parameter Visit 1/ screening Visit 03/ Week 4 Visit 04/Week 12
Serum Fasting LDL-Cholesterol(mg/dl) x x x
Serum Fasting Total-Cholesterol(mg/dl) x x x
Serum Triglyceride (mg/dl) x   x
HbA1c x   x
Fasting Plasma Glucose (FPG ) x x x
SGOT (AST) x   x
SGPT (ALT) x   x
S. Alkaline Phosphatase x   x
Total Bilirubin x   x
Blood Urea Nitrogen (BUN) x   x
SerumCreatinine x   x
Hematology/CBC x   x
Urine analysis x   x

*Subjects should be in fasting condition for at least 08-10 hours, without having any food and medication during above mentioned visits. Drinking water during fasting is acceptable.