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NCT00092560 Clinical Trial

Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)

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 NCT00092560
Other study ID # 0653-036
Secondary ID 2004_035
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2002
Est. completion date December 2003

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

Description:

The duration of treatment is 18 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 587
Est. completion date December 2003
Est. primary completion date December 2003
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 (1)

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

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma LDL-C vs. fenofibrate for 12 weeks.
Secondary All plasma lipid parameters vs. ezetimibe; all non-LDL lipid parameters vs. fenofibrate; safety and tolerability.
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