A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)

NCT ID: NCT00093899

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

611 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-09-30

Brief Summary

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The purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Detailed Description

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Conditions

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Hyperlipidemia Hypercholesterolemia Hypertriglyceridemia

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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ezetimibe (+) simvastatin

Duration of Treatment: 6 months

Intervention Type DRUG

Other Intervention Names

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MK0653A

Eligibility Criteria

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Inclusion Criteria

* Men and women 18-79 years of age with high cholesterol and high triglycerides.

Exclusion Criteria

* Individuals who do not meet specific cholesterol or triglyceride levels as required by the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 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, Roth E, Gil-Extremera B, Mendez GF, Macdonell G, Hamlin C, Perevozskaya I, Davies MJ, Kush D, Mitchel YB; Ezetimibe/Simvastatin + Fenofibrate Study Group. Efficacy and safety of the coadministration of ezetimibe/simvastatin with fenofibrate in patients with mixed hyperlipidemia. Am Heart J. 2007 Feb;153(2):335.e1-8. doi: 10.1016/j.ahj.2006.10.031.

Reference Type BACKGROUND
PMID: 17239698 (View on PubMed)

Farnier M, Perevozskaya I, Taggart WV, Kush D, Mitchel YB. VAP II analysis of lipoprotein subclasses in mixed hyperlipidemic patients on treatment with ezetimibe/simvastatin and fenofibrate. J Lipid Res. 2008 Dec;49(12):2641-7. doi: 10.1194/jlr.P800034-JLR200. Epub 2008 Jul 31.

Reference Type BACKGROUND
PMID: 18669979 (View on PubMed)

Gil-Extremera B, Mendez G, Zakson M, Meehan A, Shah A, Lin J, Mitchel Y. Efficacy and safety of ezetimibe/simvastatin co- administered with fenofibrate in mixed hyperlipidemic patients with metabolic syndrome. Metab Syndr Relat Disord. 2007 Dec;5(4):305-14. doi: 10.1089/met.2007.0011.

Reference Type BACKGROUND
PMID: 18370800 (View on PubMed)

Other Identifiers

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2004_044

Identifier Type: -

Identifier Source: secondary_id

0653A-071

Identifier Type: -

Identifier Source: org_study_id

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