Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)

Organon

Status and phase

Terminated

Phase 4

Conditions

Hypercholesterolemia

Atherosclerosis

Treatments

Drug: Placebo

Drug: Ezetimibe

Study type

Interventional

Funder types

Industry

Identifiers

NCT00651014

P03405

Details and patient eligibility

About

The study was designed to assess whether 6 weeks of co-administration of ezetimibe and simvastatin is more effective than simvastatin monotherapy in allowing patients in the CHD risk strata of the NCEP III guidelines to achieve their LDL-C target goal of <=3.0 mmol/L. As this study was to be conducted in Canada, the target LDL-C goal for patients with CHD, or type II diabetic patients >30 years old with no CHD, was <2.5 mmol/L.

Enrollment

82 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

>=18 years of age and treated with simvastatin 10 mg or 20 mg for at least 6 weeks and LDL-C levels of > 2.5 mmol/L to <=4.20 mmol/L (97 mg/dL to 160 mg/dL) at Visit 1.
history of coronary heart disease (type II diabetic patients > 30 years old with no CHD)
triglycerides <= 4.00 mmol/L drawn, and liver transaminases (ALT, AST) <=50% above the upper limit of normal at Visit 2, with no active liver disease, and/or creatine kinase (CK) <=50% above the upper limit of normal

Exclusion criteria

subjects with Body Mass Index >=35 kg/sqm at Visit 1
alcohol consumption > 14 drinks per week
pregnant or lactating
treated with any other investigational drug within 30 days prior Visit 1
previously treated with ezetimibe or participated in a clinical study with ezetimibe
any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study