CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 116 enrolled
Drug / intervention
Atorvastatin +1 moredrug
Likely dose
Atorvastatin 80mgfrom 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.

Search/NCT01785615
NCT01785615Phase 2Completed

Interactions of Thrombogenic, Lipogenic, and Inflammatory Markers in Women With the Metabolic Syndrome - Effect of Atorvastatin

University of Rochester·interventional·Posted Feb 7, 2013·Updated Jun 7, 2017

In Brief

A Phase 2 clinical trial evaluating Atorvastatin and Placebo for Metabolic Syndrome. Completed, enrolled 116 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2013
Enrollment StartNov 1, 2004
Primary CompletionDec 1, 2011
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 13.4 years ago

Interventions

Atorvastatindrug

80mg

Placeboother

80mg