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

Phase 3

Completed

• Conditions: Hypercholesterolemia; Hypertriglyceridemia

• Registration Number: NCT00092560
• Lead Sponsor: Organon and Co

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.

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Study First Submitted: 2004-09-23
• Study First Submitted QC: 2004-09-27
• Study First Posted: 2004-09-28
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 587

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma LDL-C vs. fenofibrate for 12 weeks.

Secondary Outcome Measures

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