Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)
Overview[ - collapse ][ - ]
Purpose | 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? |
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Condition | Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease |
Intervention | Drug: avandia Drug: metformin Drug: losartan |
Phase | Phase 2 |
Sponsor | Brooke Army Medical Center |
Responsible Party | Brooke Army Medical Center |
ClinicalTrials.gov Identifier | NCT00699036 |
First Received | June 16, 2008 |
Last Updated | June 18, 2009 |
Last verified | June 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | June 16, 2008 |
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Last Updated Date | June 18, 2009 |
Start Date | April 2007 |
Estimated Primary Completion Date | August 2009 |
Current Primary Outcome Measures | liver biopsy histologic improvement [Time Frame: end of study] [Designated as safety issue: No] |
Current Secondary Outcome Measures | serum transaminases [Time Frame: throughout study (ongoing)] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH) |
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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 |
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 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? |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: avandia 4 mg twice daily Drug: metformin 500 mg twice daily for 48 weeks Drug: losartan losartan 50 mg once daily |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 165 |
Estimated Completion Date | August 2009 |
Estimated Primary Completion Date | July 2009 |
Eligibility Criteria | 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 | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00699036 |
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Other Study ID Numbers | C.2007.066 |
Has Data Monitoring Committee | Yes |
Information Provided By | Brooke Army Medical Center |
Study Sponsor | Brooke Army Medical Center |
Collaborators | Not Provided |
Investigators | Principal Investigator: Dawn M Torres, MD Brooke Army Medical Center |
Verification Date | June 2009 |
Locations[ + expand ][ + ]
Brooke Army Medical Center | San Antonio, Texas, United States, 78234 Contact: Dawn M Torres, MD | 210-916-5649Principal Investigator: Dawn M Torres, MD Recruiting |
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