Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)

NCT ID: NCT00092560

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

587 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2003-12-31

Brief Summary

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The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Detailed Description

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The duration of treatment is 18 weeks.

Conditions

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Hypercholesterolemia Hypertriglyceridemia

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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MK0653, ezetimibe

Intervention Type DRUG

Comparator: fenofibrate monotherapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* High cholesterol and high triglycerides

Exclusion Criteria

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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, Freeman MW, Macdonell G, Perevozskaya I, Davies MJ, Mitchel YB, Gumbiner B; Ezetimibe Study Group. Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia. Eur Heart J. 2005 May;26(9):897-905. doi: 10.1093/eurheartj/ehi231. Epub 2005 Mar 21.

Reference Type BACKGROUND
PMID: 15781429 (View on PubMed)

Farnier M, Dong Q, Shah A, Johnson-Levonas AO, Brudi P. Low incidence of paradoxical reductions in HDL-C levels in dyslipidemic patients treated with fenofibrate alone or in combination with ezetimibe or ezetimibe/simvastatin. Lipids Health Dis. 2011 Nov 16;10:212. doi: 10.1186/1476-511X-10-212.

Reference Type DERIVED
PMID: 22087637 (View on PubMed)

Other Identifiers

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2004_035

Identifier Type: -

Identifier Source: secondary_id

0653-036

Identifier Type: -

Identifier Source: org_study_id

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