MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)

A Multicenter, Double-Blind, Randomized, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Patients With Hypercholesterolemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092690

Enrollment

1902

Registered

2004-09-28

Start date

2003-06-30

Completion date

2004-03-31

Last updated

2024-05-10

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

Conditions

Hypercholesterolemia

Brief summary

This study is to assess the safety and efficacy of an investigational drug as compared to an approved drug to reduce specific cholesterol levels.

Detailed description

The duration of treatment is 6 weeks.

Interventions

DRUGMK0653A, ezetimibe (+) simvastatin

DRUGComparator: atorvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Elevated cholesterol

Exclusion criteria

* Unstable medical conditions or significant heart problems within 3 months prior to first study visit.

Design outcomes

Primary

Measure	Time frame
Plasma LDL-C averaged across all doses after 6 weeks	—

Secondary

Measure	Time frame
Plasma LDL-C for each dose; plasma HDL-C averaged across all doses	—

Outcome results

None listed

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