NCT00699036

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

Rosiglitazone Versus Rosiglitazone and Metformin (Avandamet) Versus Combination Rosiglitazone and Losartan in the Treatment of Nonalcoholic Steatohepatitis (NASH). A Prospective, Open-Label, Randomized Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Nonalcoholic Steatohepatitis
• Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	avandia	4 mg twice daily
DRUG	metformin	500 mg twice daily for 48 weeks
DRUG	losartan	losartan 50 mg once daily

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2008-06-17
• Last updated: 2009-06-19

Locations

1 site across 1 country: United States