Vascular and Metabolic Effects of Vytorin

Gachon University Gil Medical Center

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: vytorin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01660945

GMC-201102

Details and patient eligibility

About

The investigator hypothesize that vytorin may improve vascular and insulin resistance in hypercholesterolemic patients

Enrollment: 204 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hypercholesterolemia

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, including a placebo group

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo

vytorin 10

Active Comparator group

Description:

vytorin 10 mg

Treatment:

Drug: vytorin

vytorin 20

Active Comparator group

Description:

vytorin 20 mg

Treatment:

Drug: vytorin