drugset / Trial / NCT01785615

Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin

NCT01785615

Phase 1/2 Completed 116 enrolled University of Rochester Pfizer · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

Little is known regarding the association of individual components of the metabolic syndrome (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional markers in women with this syndrome. Less is known about adequate treatment as the pathological mechanism of this syndrome is not well understood. The purpose of this study is two fold; 1. To determine basic differences in biochemical and cardiovascular structural markers in women with and those without MBS and their association with the individual components of MBS. 2. To determine the impact of atorvastatin to lower the risk factors of Metabolic Syndrome. Atorvastatin is one of the most effective drugs approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol. It belongs to a class of drugs called statins and its role in primary prevention is still unclear. Thus this population seems to be an ideal group that may benefit from this intervention.

Timeline

Start
2004-11
Primary completion
2011-12
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 80 mg

Indications