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

The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone + metformin or rosiglitazone + 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?

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• Drug: avandia
  • 4 mg twice daily
• Drug: avandia plus metformin
  • 4/500 mg twice daily for 48 weeks
• Drug: avandia plus losartan
  • avandia 4 mg twice daily and losartan 50 mg once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • avandia
• Experimental: 2
  • avandia plus metformin
• Experimental: 3
  • avandia plus losartan

Primary Measures

• liver biopsy histologic improvement
  • Time Frame: end of study
    Safety Issue?: No

Secondary Measures

• serum transaminases
  • Time Frame: throughout study (ongoing)
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Patients between 18-70 years old
• 2. Negative urine pregnancy test in females.
• 3. History of elevated liver associated enzymes (ALT >40)
• 4. Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH.

Exclusion Criteria:

• 1. ALT greater than three times normal
• 2. NYHA class 3 or 4 heart failure
• 3. Any congestive heart failure patient on insulin
• 4. Patients on one of the 3 study drugs within the past 3 months prior to enrollment.
• 5. Alcohol consumption >20 gm/day in a female and >30 gm/day in a male.
• 6. Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis.
• 7. Serum creatinine on initial screening of greater than 1.4
• 8. Known hypersensitivity to rosiglitazone, metformin, or losartan.
• 9. Known history of diabetic ketoacidosis.
• 10. Female that is breastfeeding.
• 11. Insulin dependent diabetic.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Brooke Army Medical Center

Overall Clinical Trial Officials and Contacts

Dawn M Torres, MD Principal Investigator Brooke Army Medical Center  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699036

Study ID Number: C.2007.066

ClinicalTrials.gov Identifier: NCT00699036

Health Authority: United States: Federal Government