To Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet In Patients With Hypercholesterolemia (0733-264)

• Status: Completed
• Trial end date: 2006-04-04
• 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: Merck Sharp & Dohme Corp.
• 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 arrhythmias, unstable angina pectoris

• Myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months of visit 1

• Uncontrolled hypertension with systolic blood pressure > 160 mmhg or diastolic > 100 mmhg at visit 1.

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