Evaluation of the Effects of Simvastatin 40mg

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardinal Tien Hospital
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Male or female patient, >18 years of age

• Patients with hypercholesterolemia who meet the following lipid criteria:

1. primary cholesterolemia: total cholesterol>=240 mg/dl or ldl-c >= 160 mg/dl

2. secondary cholesterolemia (patients with cad, dm): ldl-c>=130 mg/dl

• The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study

Exclusion Criteria:

• Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmia, unstable angina

• Hypertension (based on the atp 3 guidelines)

• Taking potent lipid-lowering agents

• Unstable diabetes (hba1c >9%) or newly diagnosed (within 3 months), or a change in anti-diabetes medications within 3 months of screening