Vascular and Metabolic Effects of Vytorin vs Simvastatin

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: placebo; Drug: vytorin; Drug: simvastatin

• Registration Number: NCT01666067
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Status Verified: 2012-08
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-16
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Last Update Submitted: 2014-11-01
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo
vytorin	vytorin	vytorin
simvastatin	simvastatin	simvastatin

Primary Outcome Measures

Name	Time	Method
flow-mediated dilation	8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
insulin resistance	8 weeks of treatment

Trial Locations

Locations (1)

Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of