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An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes
This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00576667
First received: December 18, 2007
Last updated: April 18, 2016
Last verified: April 2016
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Purpose
The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).
| Condition | Intervention | Phase |
|---|---|---|
| Fatty Liver | Drug: Rimonabant Drug: Placebo (for Rimonabant) | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Non-diabetic Patients With Nonalcoholic Steatohepatitis (NASH) |
Resource links provided by NLM:
Genetics Home Reference related topics:
non-alcoholic fatty liver disease
MedlinePlus related topics:
Liver Diseases
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS) [ Time Frame: Baseline to 24 months ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 165 |
| Study Start Date: | January 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rimonabant
Rimonabant 20 mg once daily.
|
Drug: Rimonabant
Tablet, oral administration
Other Names:
|
|
Placebo Comparator: Placebo
Placebo (for Rimonabant) once daily.
|
Drug: Placebo (for Rimonabant)
Tablet, oral administration
|
Detailed Description:
The total duration per patient will be approximately 28 months including a 24-month double-blind treatment period.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with diagnosis of NASH
Exclusion Criteria:
- Excessive alcohol use
- Presence of diabetes mellitus
- Other chronic liver disease
- Previous or current hepatocellular carcinoma
- Use of medication known to cause steatosis
- Previous bariatric surgery
- Pregnancy or breastfeeding
- Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00576667
Show 24 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576667
Show 24 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00576667 History of Changes |
| Other Study ID Numbers: |
EFC10143 2007-003013-14 ( EudraCT Number ) |
| Study First Received: | December 18, 2007 |
| Last Updated: | April 18, 2016 |
Keywords provided by Sanofi:
|
NASH chronic liver disease |
Additional relevant MeSH terms:
|
Fatty Liver Non-alcoholic Fatty Liver Disease Liver Diseases Digestive System Diseases Rimonabant Cannabinoid Receptor Antagonists |
Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 23, 2017