At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 100 enrolled
Drug / intervention
Simvastatin +1 moredrug
Likely dose
Simvastatin 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Simvastatin and Simvastatin/Ezetimibe for Metabolic Syndrome. Completed, enrolled 100 participants across 5 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolic Syndrome
CountriesNetherlands, Spain
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartApr 2009
Primary CompletionSep 2010
TodayJul 2026
First PostedJan 7, 2009
Enrollment StartApr 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.5 years ago
Interventions
Simvastatindrug
6 weeks of treatment with simvastatin 80 mg
Simvastatin/Ezetimibedrug
6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg combination