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Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED)

NCT ID: NCT00092612

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

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-06-30

Brief Summary

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The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current 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 have cholesterol levels within normal ranges as identified 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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Farnier M, Volpe M, Massaad R, Davies MJ, Allen C. Effect of co-administering ezetimibe with on-going simvastatin treatment on LDL-C goal attainment in hypercholesterolemic patients with coronary heart disease. Int J Cardiol. 2005 Jul 10;102(2):327-32. doi: 10.1016/j.ijcard.2005.01.022.

Reference Type BACKGROUND
PMID: 15982505 (View on PubMed)

Other Identifiers

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2004_040

Identifier Type: -

Identifier Source: secondary_id

0653-802

Identifier Type: -

Identifier Source: org_study_id

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