Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED)

NCT ID: NCT00092573

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 576 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2004-11-30

Brief Summary

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

Detailed Description

The duration of treatment is 48 weeks.

Conditions

Hypercholesterolemia; Hypertriglyceridemia

Study Design

• Primary Study Purpose: TREATMENT

Interventions

MK0653, ezetimibe

Intervention Type: DRUG

Comparator: fenofibrate monotherapy

Intervention Type: DRUG

Eligibility Criteria

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

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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)

McKenney JM, Farnier M, Lo KW, Bays HE, Perevozkaya I, Carlson G, Davies MJ, Mitchel YB, Gumbiner B. Safety and efficacy of long-term co-administration of fenofibrate and ezetimibe in patients with mixed hyperlipidemia. J Am Coll Cardiol. 2006 Apr 18;47(8):1584-7. doi: 10.1016/j.jacc.2005.11.072. Epub 2006 Mar 30.

Reference Type: BACKGROUND

PMID: 16630994 (View on PubMed)

Tribble DL, Farnier M, Macdonell G, Perevozskaya I, Davies MJ, Gumbiner B, Musliner TA. Effects of fenofibrate and ezetimibe, both as monotherapy and in coadministration, on cholesterol mass within lipoprotein subfractions and low-density lipoprotein peak particle size in patients with mixed hyperlipidemia. Metabolism. 2008 Jun;57(6):796-801. doi: 10.1016/j.metabol.2008.01.026.

Reference Type: BACKGROUND

PMID: 18502262 (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

2004_036

Identifier Type: -

Identifier Source: secondary_id

0653-036 Extension

Identifier Type: -

Identifier Source: org_study_id