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

Phase 4TerminatedNCT00651014

Organon and Co82 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypercholesterolemia Atherosclerosis

Interventions

EzetimibeDRUG

oral tablet; ezetimibe 10 mg once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)

PlaceboDRUG

oral tablet; ezetimibe placebo once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of patients reaching LDL-C goal of < 2.5 mmol/L (97 mg/dL) at endpoint.

Time frame: 6 weeks

Secondary Outcomes

Percent change from baseline to endpoint in LDL-C.

Time frame: 6 weeks

Percent change from baseline to endpoint in total cholesterol (TC) triglycerides, HDL-C, non-HDL-C, LDL-C/HDL-C ratio, TC/HDL-C ratio, and apolipoprotein B.

Time frame: 6 weeks

Safety/tolerability: adverse events, laboratory test results, vital signs.

Time frame: Throughout study

Data from ClinicalTrials.gov

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