Status:
UNKNOWN
Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)
Lead Sponsor:
Brooke Army Medical Center
Conditions:
Nonalcoholic Steatohepatitis
Nonalcoholic Fatty Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 st...
Eligibility Criteria
Inclusion
- Patients between 18-70 years old
- Negative urine pregnancy test in females
- History of elevated liver associated enzymes (ALT \> 40)
- Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH
Exclusion
- ALT greater than three times normal
- NYHA class 3 or 4 heart failure
- Any congestive heart failure patient on insulin
- Patients on one of the 3 study drugs within the past 3 months prior to enrollment
- Alcohol consumption \>20 gm/day in a female and \> 30 gm/day in a male
- Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis
- Serum creatinine on initial screening of greater than 1.4
- Known hypersensitivity to rosiglitazone, metformin, or losartan
- Known history of diabetic ketoacidosis
- Female that is breastfeeding
- Insulin dependent diabetic
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00699036
Start Date
April 1 2007
End Date
August 1 2009
Last Update
June 19 2009
Active Locations (1)
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1
Brooke Army Medical Center
San Antonio, Texas, United States, 78234