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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10mg or 20mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease and/or Type II Diabetes

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00651014

Enrollment

Registered

2008-04-02

Start date

2004-01-31

Completion date

2006-06-30

Last updated

2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Hypercholesterolemia

Brief summary

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.

Interventions

DRUGEzetimibe

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients reaching LDL-C goal of < 2.5 mmol/L (97 mg/dL) at endpoint.	6 weeks

Secondary

Measure	Time frame
Percent change from baseline to endpoint in LDL-C.	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.	6 weeks
Safety/tolerability: adverse events, laboratory test results, vital signs.	Throughout study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026