Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)

A Multicenter, Double-Blind, Randomized, Parallel Group, 28-Week Study to Evaluate the Efficacy and Safety of Ezetimibe and Simvastatin Co-administration Versus Atorvastatin in Patients With Hypercholesteremia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092716

Enrollment

655

Registered

2004-09-28

Start date

2002-05-31

Completion date

2003-04-30

Last updated

2024-08-15

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

Conditions

Hypercholesterolemia

Brief summary

The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.

Interventions

DRUGMK0653, ezetimibe / Duration of Treatment: 28 weeks

DRUGComparator: atorvastatin / Duration of Treatment: 28 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Elevated cholesterol levels

Exclusion criteria

* Liver disease * Unstable medical conditions

Design outcomes

Primary

Measure	Time frame
To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.	—

Secondary

Measure	Time frame
Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C	—
Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level	—

Outcome results

None listed

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