Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)

A Multi-center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg/Day When Added to Ongoing Therapy With a Statin Versus Statin Therapy Alone, in Patients With Hypercholesterolemia Who Have Not Reached National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Target LDL-Cholesterol Level

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092586

Enrollment

2904

Registered

2004-09-28

Start date

2002-09-30

Completion date

2003-10-31

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 6-week study is to compare the reduction in specific levels of cholesterol in patients with high cholesterol.

Detailed description

The duration of treatment is 6 weeks.

Interventions

DRUGComparator: statins

DRUGMK0653, ezetimibe

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* High cholesterol levels that are identified by specific laboratory values

Exclusion criteria

* Active liver disease * Any condition or situation which would interfere with participation

Design outcomes

Primary

Measure	Time frame
Percent change in LDL-C	—

Secondary

Measure	Time frame
Percentage of patients reaching NCEP ATP III target LDL-C levels	—

Outcome results

None listed

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