Clinical Trial Details
| Trial ID: | L0260 |
| Source ID: | NCT00577148 |
| Associated Drug: | Rimonabant |
| Title: | An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients With Type 2 Diabetes |
| Acronym: | -- |
| Status: | Terminated |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Fatty Liver |
| Interventions: | Drug: Rimonabant|Drug: Placebo (for Rimonabant) |
| Outcome Measures: | Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS)|Change from baseline in hepatic fibrosis score|Change from baseline in serum hyaluronate and hepatic transaminases (AST/ALT) |
| Sponsor/Collaborators: | Sanofi |
| Gender: | All |
| Age: | 18 Years and older ?? (Adult, Older Adult) |
| Phases: | Phase 3 |
| Enrollment: | 89 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | February 2008 |
| Completion Date: | February 2009 |
| Results First Posted: | -- |
| Last Update Posted: | May 18, 2016 |
| Locations: | Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States|Sanofi-Aventis Administrative Office, Buenos Aires, Argentina|Sanofi-Aventis Administrative Office, Cove, New South Wales, Australia|Sanofi-Aventis Administrative Office, Diegem, Belgium|Sanofi-Aventis Administrative Office, Sao Paulo, Brazil|Sanofi-Aventis Administrative Office, Santiago, Chile|Sanofi-Aventis Administrative Office, Shangai, China|Sanofi-Aventis Administrative Office, Santafe de Bogota, Colombia|Sanofi-Aventis Administrative Office, Zagreb, Croatia|Sanofi-Aventis Administrative Office, Paris, France|Sanofi-Aventis Administrative Office, Berlin, Germany|Sanofi-Aventis Administrative Office, Budapest, Hungary|Sanofi-Aventis Administrative Office, Milan, Italy|Sanofi-Aventis Administrative Office, Kuala Lumpur, Malaysia|Sanofi-Aventis Administrative Office, Mexico, Mexico|Sanofi-Aventis Administrative Office, Makati City, Philippines|Sanofi-Aventis Administrative Office, Warszawa, Poland|Sanofi-Aventis Administrative Office, Porto Salvo, Portugal|Sanofi-Aventis Administrative Office, Puerto Rico, Puerto Rico|Sanofi-Aventis Administrative Office, Bucuresti, Romania|Sanofi-Aventis Administrative Office, Barcelona, Spain|Sanofi-Aventis Administrative Office, Geneva, Switzerland|Sanofi-Aventis Administrative Office, Taipei, Taiwan|Sanofi-Aventis Administrative Office, Guildford, Surrey, United Kingdom |
| URL: | https://ClinicalTrials.gov/show/NCT00577148 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D305 | Rimonabant | Chemical drug | DB06155 | CNR1 antagonist | Antialcoholic drug; CNS drug | Under clinical trials | Details |
| D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
| D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |
| D316 | S-adenosyl-L-methionine | Chemical drug | DB00118 | GNMT cofactor | Antiviral | Under clinical trials | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |