A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)

Organon

Status and phase

Completed

Phase 3

Conditions

Coronary Disease

Treatments

Drug: Comparator: simvastatin / Duration of Treatment: 27 Weeks

Drug: MK0653, ezetimibe / Duration of Treatment: 27 Weeks

Drug: MK0733, simvastatin / Duration of Treatment: 27 Weeks

Study type

Interventional

Funder types

Industry

Identifiers

NCT00551447

MK0653-023

0653-023

2006_555

Details and patient eligibility

About

This purpose of this study is to determine if the administration of ezetimibe and simvastatin together is more effective than simvastatin alone in lowering LDL-C levels to a goal of <100 mg/dL in patients at risk for Heart Disease.

Enrollment

616 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women aged 18 to 80 at risk for Heart Disease who have LDL-C levels greater than or equal to 130 mg/dL and triglyceride level less than or equal to 350 mg/dL
Patients must be able to maintain the National Cholesterol Education Program diet throughout the course of the study

Exclusion criteria

Patients are excluded from the study if their weight is less than 50% of ideal body weight, if they are pregnant or lactating, have congestive heart failure, uncontrolled heart rhythm problems or a recent heart attack, coronary artery bypass surgery, or angioplasty. Additionally, patients with poorly controlled Type 1 or 2 diabetes mellitus, kidney disease, uncontrolled endocrine or metabolic disease, are known HIV positive, and uncontrolled high blood pressure