Vascular and Metabolic Effects of Vytorin vs Simvastatin

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01666067

Enrollment

204

Registered

2012-08-16

Start date

2011-11-30

Completion date

2012-11-30

Last updated

2014-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

insulin resistance

Brief summary

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

Interventions

DRUGplacebo

DRUGvytorin

DRUGsimvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

25 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
flow-mediated dilation	8 weeks of treatment

Secondary

Measure	Time frame
insulin resistance	8 weeks of treatment

Countries

South Korea

Outcome results

None listed

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