NCT00817843

The PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin Study

Multicenter,Double Blind,Randomized, 2-period, Crossover Study to Compare Ezetimibe/Simvastatin (10mg/10 mg) Combination Tablet Versus Simvastatin 80mg Tablet on Postprandial Arterial Endothelial Function in Patients With Metabolic Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: dr.Frank L.J. Visseren · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether low-dose simvastatin in combination with ezetimibe in comparison to high-dose simvastatin alone, has a beneficial effect on the function of the endothelium after an oral fat load in patients with metabolic syndrome.

Detailed description

Metabolic syndrome is defined as a group of cardiovascular risk factors and is mainly driven by the epidemic of obesity. High blood lipid levels after a meal may be an important risk factor for cardiovascular disease. In this study we will investigate whether simvastatin in combination with ezetimibe vs. simvastatin alone, has a beneficial effect on the lipid levels after a meal, but more importantly, whether we can measure a difference in function of the endothelium. In a small pilot study we already found that the combination had a beneficial effect in comparison with simvastatin alone. Now we want to solidify these findings in a larger study.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	Simvastatin	6 weeks of treatment with simvastatin 80 mg
DRUG	Simvastatin/Ezetimibe	6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg combination

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-01-07
• Last updated: 2013-01-09
• Results posted: 2013-01-09

Locations

5 sites across 2 countries: Netherlands, Spain