A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia
Information source: Merck
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemia; Hypercholesterolemia; Hypertriglyceridemia
Intervention: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 months (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
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).
Clinical Details
Official title: A Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Fenofibrate Coadministration in Patients With Mixed Hyperlipidemia
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Plasma LDL-C.
Secondary outcome: Plasma HDL-C, non-HDL-C, and TG. Tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Related publications: 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.
Starting date: December 2004
Last updated: May 17, 2007
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