Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092599

Enrollment

410

Registered

2004-09-27

Start date

2003-02-28

Completion date

2004-07-31

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

Coronary Disease, Hypercholesterolemia

Keywords

Elevated Cholesterol

Brief summary

This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an approved cholesterol lowering medication.

Detailed description

The duration of treatment is 10 weeks.

Interventions

DRUGMK0653, ezetimibe

DRUGComparator: ezetimibe, placebo

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

* Patients with elevated cholesterol and coronary heart disease

Exclusion criteria

* Patients who do not meet specific cholesterol levels as required by the study

Design outcomes

Primary

Measure	Time frame
Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment	—

Secondary

Measure	Time frame
Safety and tolerability.	—

Outcome results

None listed

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