Viewing Study NCT00819403



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Last Modification Date: 2024-10-26 @ 9:59 AM
Study NCT ID: NCT00819403
Status: COMPLETED
Last Update Posted: 2020-01-14
First Post: 2009-01-07

Brief Title: Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: The Effects of EzetimibeSimvastatin Versus Simvastatin Alone on Platelet and Inflammatory Biomarkers in Patients With the Metabolic Syndrome
Status: COMPLETED
Status Verified Date: 2020-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome
Detailed Description: 1 To assess the ex vivo effects of ezetimibesimvastatin ES Vytorin 1040mg and simvastatin S Zocor 40mg on platelet and inflammation biomarkers in patients with documented metabolic syndrome
2 To compare platelet-related effects including PAR-1 receptor inhibition of ES with those of the established anti-platelet agents including aspirin clopidogrel intravenous and oral glycoprotein IIbIIIa inhibitors
3 To determine whether the addition of ezetimibe will yield extra protection beyond lipid modulation in the reduction of inflammation and platelet activation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
MSP-JV IISP 32031 None None None