The PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin Study

Phase 4

Completed

• Conditions: Metabolic Syndrome
• Interventions: Drug: Simvastatin; Drug: Simvastatin/Ezetimibe

• Registration Number: NCT00817843
• Lead Sponsor: dr.Frank L.J. Visseren

Brief 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.

Study Timeline

• Study First Submitted: 2009-01-06
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Study Start: 2009-04
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2012-06-18
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-04
• Last Update Submitted: 2013-01-04
• Results First Posted: 2013-01-09
• Last Update Posted: 2013-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First Simva 80mg then Simvai/Eze10/10mg	Simvastatin/Ezetimibe	First 6 weeks of Simvastatin 80mg, then 6 weeks of Simvastatin/Ezetimibe 10/10mg after 6 weeks of placebo washout
First Simva/Eze 10/10mg then Simva 80mg	Simvastatin/Ezetimibe	First 6 weeks of Simvastatin/Ezetimibe 10/10mg, then 6 weeks of Simvastatin 80mg after 6 weeks of placebo washout
First Simva/Eze 10/10mg then Simva 80mg	Simvastatin	First 6 weeks of Simvastatin/Ezetimibe 10/10mg, then 6 weeks of Simvastatin 80mg after 6 weeks of placebo washout
First Simva 80mg then Simvai/Eze10/10mg	Simvastatin	First 6 weeks of Simvastatin 80mg, then 6 weeks of Simvastatin/Ezetimibe 10/10mg after 6 weeks of placebo washout

Primary Outcome Measures

Name	Time	Method
Treatment Difference in (Postprandial-Fasting) FMD	After 6 weeks of treatment	A comparison of the postprandial minus fasting change in FMD under treatment with simvastatin 80 mg versus simvastatin 10/10 mg

Secondary Outcome Measures

Name	Time	Method
Postprandial Endopat Measurement	after 6 weeks of treatment (crossover)
Preprandial Endothelial Function Measured by FMD	after 6 weeks of treatment (crossover)
Preprandial Endopat Measurement	after 6 weeks of treatment (crossover)

Trial Locations

Locations (5)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Vascular Research Center Hoorn; 🇳🇱 Hoorn, Netherlands

Department of Vascular Medicine UMC Utrecht; 🇳🇱 Utrecht, Netherlands

Tweesteden Ziekenhuis; 🇳🇱 Waalwijk, Netherlands

Hospital Arnau de Vilanova; 🇪🇸 Lleida, Spain