Vascular and Metabolic Effects of Vytorin

Phase 4

Completed

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

• Registration Number: NCT01660945
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-07
• Status Verified: 2012-08
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-09
• 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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo
vytorin 20	vytorin	vytorin 20 mg
vytorin 10	vytorin	vytorin 10 mg

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