A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)

A Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Fenofibrate Coadministration in Patients With Mixed Hyperlipidemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00093899

Enrollment

611

Registered

2004-10-08

Start date

2004-11-30

Completion date

2005-09-30

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

Hyperlipidemia, Hypercholesterolemia, Hypertriglyceridemia

Keywords

Mixed Hyperlipidemia

Brief summary

The purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Interventions

DRUGezetimibe (+) simvastatin

Duration of Treatment: 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Men and women 18-79 years of age with high cholesterol and high triglycerides.

Exclusion criteria

* Individuals who do not meet specific cholesterol or triglyceride levels as required by the study.

Design outcomes

Primary

Measure	Time frame
Plasma LDL-C.	—

Secondary

Measure	Time frame
Plasma HDL-C, non-HDL-C, and TG. Tolerability	—

Outcome results

None listed

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