Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

Gachon University Gil Medical Center

Status and phase: Completed; Phase 4

Conditions: Hypertriglyceridemia

Treatments: Drug: fenofibrate; Drug: fenofibrate/omega; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01666041

GMC-201202

Details and patient eligibility

About

The investigators hypothesize that fenofibrate/omega will improve insulin resistance compared with fenofibrate

Enrollment: 120 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hypertriglyceridemia

Exclusion criteria

• moderate or severe hypertension, uncontrolled diabetes (HbA1c > 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo

fenofibrate/omega

Active Comparator group

Description:

fenofibrate/omega

Treatment:

Drug: fenofibrate/omega

fenofibrate

Active Comparator group

Description:

fenofibrate

Treatment:

Drug: fenofibrate