Vascular and Metabolic Effects of Rosuvastatin

Phase 4

Completed

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

• Registration Number: NCT01660919
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Status Verified: 2012-08
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-09
• Primary Completion: 2013-01
• Study Completion: 2013-12
• Last Update Submitted: 2014-11-01
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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
rosuvastatin 5	rosuvastatin	rosuvastatin 5 mg
rosuvastatin 10	rosuvastatin	rosuvastatin 10 mg
rosuvastatin 20	rosuvastatin	rosuvastatin 20 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