Vascular and Metabolic Effects of Vytorin vs Simvastatin

Gachon University Gil Medical Center

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: placebo; Drug: simvastatin; Drug: vytorin

Study type: Interventional

Funder types: Other

Identifiers

NCT01666067

GMC-201110

Details and patient eligibility

About

The investigators hypothesize that vytorin will improve insulin resistance compared with simvastatin

Enrollment: 204 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hypercholesterolemic patients (LDL cholesterol levels>100 mg/dl)

Exclusion criteria

• overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c > 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 3 patient groups

placebo

Active Comparator group

Description:

placebo

Treatment:

Drug: placebo

vytorin

Active Comparator group

Description:

vytorin

Treatment:

Drug: vytorin

simvastatin

Active Comparator group

Description:

simvastatin

Treatment:

Drug: simvastatin