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

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).

Completed

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Key information

Conditions

Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Hypertriglyceridemia Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The duration of treatment is 18 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0653, ezetimibe

Drug

Comparator: fenofibrate monotherapy

Drug

Primary outcomes

Plasma LDL-C vs. fenofibrate for 12 weeks.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Sep 28, 2004
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed