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

NCT ID: NCT00092599

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-07-31

Brief Summary

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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.

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Detailed Description

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The duration of treatment is 10 weeks.

Conditions

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Hypercholesterolemia Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0653, ezetimibe

Intervention Type DRUG

Comparator: ezetimibe, placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Brohet C, Banai S, Alings AM, Massaad R, Davies MJ, Allen C. LDL-C goal attainment with the addition of ezetimibe to ongoing simvastatin treatment in coronary heart disease patients with hypercholesterolemia. Curr Med Res Opin. 2005 Apr;21(4):571-8. doi: 10.1185/030079905X382004.

Reference Type BACKGROUND
PMID: 15899106 (View on PubMed)

Other Identifiers

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2004_039

Identifier Type: -

Identifier Source: secondary_id

0653-801

Identifier Type: -

Identifier Source: org_study_id

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