A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)

NCT ID: NCT00132717

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

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-01

Study Completion Date

2007-06-01

Brief Summary

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The purpose of this study is to investigate the effect of an investigational cholesterol-lowering drug in patients who are currently taking an approved medication for hypercholesterolemia (high cholesterol levels) and have been hospitalized for a heart problem.

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MK0653A (ezetimibe [+] simvastatin)

Intervention Type DRUG

Comparator: atorvastatin

Intervention Type DRUG

Comparator: fluvastatin

Intervention Type DRUG

Comparator: lovastatin

Intervention Type DRUG

Comparator: pravastatin

Intervention Type DRUG

Comparator: rosuvastatin

Intervention Type DRUG

Comparator: simvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients greater than 18 years old, who were admitted to a hospital for an investigation of a heart problem and are currently receiving an approved medication to lower cholesterol

Exclusion Criteria

* Patients who have congestive heart failure (CHF), uncontrolled high blood pressure, poorly controlled blood sugar, impaired kidney function, or HIV.
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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Reckless JP, Henry P, Pomykaj T, Lim ST, Massaad R, Vandormael K, Johnson-Levonas AO, Lis K, Brudi P, Allen C. Lipid-altering efficacy of ezetimibe/simvastatin 10/40 mg compared with doubling the statin dose in patients admitted to the hospital for a recent coronary event: the INFORCE study. Int J Clin Pract. 2008 Apr;62(4):539-54. doi: 10.1111/j.1742-1241.2008.01697.x. Epub 2008 Feb 11.

Reference Type BACKGROUND
PMID: 18266852 (View on PubMed)

Brudi P, Reckless JP, Henry DP, Pomykaj T, Lim ST, Massaad R, Vandormael K, Johnson-Levonas AO. Efficacy of ezetimibe/simvastatin 10/40 mg compared to doubling the dose of low-, medium- and high-potency statin monotherapy in patients with a recent coronary event. Cardiology. 2009;113(2):89-97. doi: 10.1159/000172795. Epub 2008 Nov 15.

Reference Type BACKGROUND
PMID: 19018143 (View on PubMed)

Other Identifiers

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2004_046

Identifier Type: -

Identifier Source: secondary_id

0653A-808

Identifier Type: -

Identifier Source: org_study_id

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