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

Phase 3

Completed

• Conditions: Hypercholesterolemia; Hypertriglyceridemia

• Registration Number: NCT00092573
• Lead Sponsor: Organon and Co

Brief 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).

Detailed Description

The duration of treatment is 48 weeks.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2004-09-23
• Study First Submitted QC: 2004-09-27
• Study First Posted: 2004-09-28
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 576

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
Tolerability

Secondary Outcome Measures

Name	Time	Method
Plasma LDL-C, HDL-C and triglycerides after 12 weeks.