CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 53 enrolled
Drug / intervention
Rosiglitazone +2 moredrug
Likely dose
Rosiglitazone 4 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.

Search/NCT00831129
NCT00831129Phase 3Completed
CompareCT.gov

Effects of Simvastatin and Rosiglitazone Combination in Patients With the Metabolic Syndrome.

University of Chicago·interventional·Posted Jan 28, 2009·Updated Feb 10, 2017

In Brief

A Phase 3 clinical trial evaluating Rosiglitazone, Placebo Rosiglitazone, and 1 other intervention for Pre-diabetes. Completed, enrolled 53 participants across 1 site.

Detailed Summary

The purpose of this research study is to examine if a combination of a cholesterol lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective in improving vascular inflammation (irritation of the vessels that transport your blood) and other cardiovascular risk factors than the taking of simvastatin alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre-diabetes
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2009
Enrollment StartSep 1, 2006
Primary CompletionMar 1, 2011
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.4 years ago

Interventions

Rosiglitazonedrug

4 mg daily

Placebo Rosiglitazonedrug

1 tab daily

Simvastatindrug

40 mg daily