Health Condition 1: null- HYPERCHOLESTROLEMIC PATIENTS
Conditions
Interventions
Intervention1: PITAVASTATIN 4mg oral once daily: PERCENTAGE CHANGE FROM BASELINE LOW DENSITY LIPOPROTEIN-CHOLESTEROL AT THE END OF WEEK 8
OF USING DRUG
Control Intervention1: ROSUVASTATIN 10mg oral o
Sponsors
FR MULLER MEDICAL COLLEGE
Eligibility
Inclusion criteria
Inclusion criteria: • Males and females (age 18-75 years). • Non-pregnant, non-lactating female. • Eligible and able to participate and have given informed consent. • Diagnosis of hypercholesterolemia
Exclusion criteria
Exclusion criteria: • History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury. • Liver disease. • Impaired renal function. • Uncontrolled hypothyroidism. • Severe acute illness or severe trauma in the last 3 months. • Major surgery, 3 months prior to Visit 1. • Significant cardiovascular disease (CVD) prior to randomization. • Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. • History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of >100 beats per minute at rest. • History of symptomatic cerebrovascular disease. • Known muscular or neuromuscular disease of any type. • Neoplastic disease. • Current or recent use of supplements known to alter lipid metabolism. • Hypersensitivity reactions to other HMG-CoA reductase inhibitors. • Resistant to lipid-lowering medications, known hypersensitivity or intolerance to any lipid lowering agent. • Signs of mental dysfunction or other factors likely to limit ability to cooperate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢0Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at the end of Week 8 [ Time Frame: Baseline to 8 weeks ]Timepoint: 0 WEEKS 8 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Percent Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline to 8 Weeks ] â?¢ Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline to 8 weeks ] â?¢ TC:HDL-C Ratio [ Time Frame: 8 weeks ] â?¢ Triglycerides (TG) [Time Frame: 8 weeks].Timepoint: O WEEKS 8 WEEKS | — |
Countries
India
Contacts
Public ContactAnkith Rai
Rajiv Gandhi University Of Health Sciences
Outcome results
None listed