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

Phase 4

Terminated

• Conditions: Hypercholesterolemia; Atherosclerosis
• Interventions: Drug: Ezetimibe; Drug: Placebo

• Registration Number: NCT00651014
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-02
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ezetimibe	Ezetimibe	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

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