drugset / Trial / NCT00699036

Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)

NCT00699036

Phase 2 Unknown 165 enrolled Brooke Army Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?

Timeline

Start
2007-04
Primary completion
2009-07
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Losartan Other / unclassified 50 mg
Subject Metformin Small molecule 500 mg
Subject Rosiglitazone Small molecule 4 mg