MedTrace Logo

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

NCT00651014 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-02-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ezetimibe

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Merck Frosst Canada Ltd.

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2006-06-30
Completion
2006-06-30

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00651014 on ClinicalTrials.gov