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

NCT00092573 | Completed Phase 3

• 2 other identifiers: 0653-036 Extension2004_036
• Study Type: interventional
• Target: 576
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hypercholesterolemia; Hypertriglyceridemia

Keywords

Mixed hyperlipidemia (high cholesterol and high triglycerides)

Outcome Measures

Primary Outcomes (1)

• Tolerability

Secondary Outcomes (1)

• Plasma LDL-C, HDL-C and triglycerides after 12 weeks.

Interventions

MK0653, ezetimibe DRUG

Comparator: fenofibrate monotherapy DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High cholesterol and high triglycerides

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (4)

• 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.

  PMID: 15781429 BACKGROUND

• 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.

  PMID: 16630994 BACKGROUND

• 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.

  PMID: 18502262 BACKGROUND

• 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.

  PMID: 22087637 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Hypertriglyceridemia; Hyperlipoproteinemia Type II

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2004
• First Posted: September 28, 2004
• Study Start: April 1, 2003
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: August 15, 2024

Record last verified: 2022-02