The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).
The total duration per patient will be approximately 28 months including a 24-month double-blind treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
165
Tablet, oral administration
Tablet, oral administration
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS)
Time frame: Baseline to 24 months
Change from baseline in hepatic fibrosis score
Time frame: Baseline to 24 months
Change from baseline in serum hyaluronate (HA)
Time frame: Baseline to 24 months
Change from baseline in hepatic transaminases (AST/ALT)
Time frame: Baseline to 24 months
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