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NCT00092573 Clinical Trial

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

Hypercholesterolemia Clinical Trial

Official title:
Evaluation of the Efficacy and Safety of Fenofibrate and Ezetimibe Coadministration in Patients With Mixed Hyperlipidemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092573
Other study ID # 0653-036 Extension
Secondary ID 2004_036
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2003
Est. completion date November 2004

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 safety and effectiveness of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Description:

The duration of treatment is 48 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 576
Est. completion date November 2004
Est. primary completion date November 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0653, ezetimibe

• Comparator: fenofibrate monotherapy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (3)

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. Epub 2005 Mar 21. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Tolerability
Secondary Plasma LDL-C, HDL-C and triglycerides after 12 weeks.
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