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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092560

Enrollment

587

Registered

2004-09-28

Start date

2002-12-31

Completion date

2003-12-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia, Hypertriglyceridemia

Keywords

mixed hyperlipidemia, high cholesterol, high triglycerides

Brief 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).

Detailed description

The duration of treatment is 18 weeks.

Interventions

DRUGMK0653, ezetimibe

DRUGComparator: fenofibrate monotherapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Plasma LDL-C vs. fenofibrate for 12 weeks.	—

Secondary

Measure	Time frame
All plasma lipid parameters vs. ezetimibe; all non-LDL lipid parameters vs. fenofibrate; safety and tolerability.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026