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

Information source: Brooke Army Medical Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease

Intervention: avandia (Drug); metformin (Drug); losartan (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Brooke Army Medical Center

Official(s) and/or principal investigator(s):
Dawn M Torres, MD, Principal Investigator, Affiliation: Brooke Army Medical Center

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?

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: liver biopsy histologic improvement

Secondary outcome: serum transaminases

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Brooke Army Medical Center, San Antonio, Texas 78234, United States; Recruiting
Dawn M Torres, MD, Phone: 210-916-5649
Dawn M Torres, MD, Principal Investigator
Stephen A Harrison, MD, Sub-Investigator
Additional Information

Starting date: April 2007
Last updated: June 18, 2009

Page last updated: February 07, 2013

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