Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia; Hypertriglyceridemia
Intervention: MK0653, ezetimibe (Drug); Comparator: fenofibrate monotherapy (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck
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).
Clinical Details
Official title: Evaluation of the Efficacy and Safety of Fenofibrate and Ezetimibe Coadministration in Patients With Mixed Hyperlipidemia
Study design: Treatment, Safety/Efficacy Study
Primary outcome: Tolerability
Secondary outcome: Plasma LDL-C, HDL-C and triglycerides after 12 weeks.
Detailed description:
The duration of treatment is 48 weeks.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Call for Information, Horsham, Pennsylvania 19044, United States
Additional Information
Related publications: Farnier M, Freeman MW, Macdonell G, Perevozskaya I, Davies MJ, Mitchel YB, Gumbiner B; the 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. Epub 2005 Mar 21. 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. Epub 2006 Mar 30.
Starting date: January 2003
Last updated: November 27, 2006
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