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NCT00093899 Clinical Trial

A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)

Hypercholesterolemia Clinical Trial

Official title:
A Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Fenofibrate Coadministration in Patients With Mixed Hyperlipidemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00093899
Other study ID # 0653A-071
Secondary ID 2004_044
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2004
Est. completion date September 2005

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 611
Est. completion date September 2005
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ezetimibe (+) simvastatin
Duration of Treatment: 6 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (3)

Farnier M, Perevozskaya I, Taggart WV, Kush D, Mitchel YB. VAP II analysis of lipoprotein subclasses in mixed hyperlipidemic patients on treatment with ezetimibe/simvastatin and fenofibrate. J Lipid Res. 2008 Dec;49(12):2641-7. doi: 10.1194/jlr.P800034-JLR200. Epub 2008 Jul 31. — View Citation

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. — View Citation

Gil-Extremera B, Mendez G, Zakson M, Meehan A, Shah A, Lin J, Mitchel Y. Efficacy and safety of ezetimibe/simvastatin co- administered with fenofibrate in mixed hyperlipidemic patients with metabolic syndrome. Metab Syndr Relat Disord. 2007 Dec;5(4):305-14. doi: 10.1089/met.2007.0011. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma LDL-C.
Secondary Plasma HDL-C, non-HDL-C, and TG. Tolerability
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