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

Organon

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: MK0733, simvastatin / Duration of Treatment: 12 Weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00398294

0733-264

2006_044

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)