Vascular and Metabolic Effects of Rosuvastatin

Gachon University Gil Medical Center

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: rosuvastatin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01660919

GMC-201105

Details and patient eligibility

About

The investigators hypothesize that rosuvastatin does-dependently worsens insulin sensitivity.

Enrollment: 160 estimated 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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160 participants in 4 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo

rosuvastatin 5

Active Comparator group

Description:

rosuvastatin 5 mg

Treatment:

Drug: rosuvastatin

rosuvastatin 10

Active Comparator group

Description:

rosuvastatin 10 mg

Treatment:

Drug: rosuvastatin

rosuvastatin 20

Active Comparator group

Description:

rosuvastatin 20 mg

Treatment:

Drug: rosuvastatin