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An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes

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ClinicalTrials.gov Identifier: NCT00576667
Recruitment Status : Terminated (Company decision taken in light of demands by certain national health authorities)
First Posted : December 19, 2007
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:
The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).

Condition or disease Intervention/treatment Phase
Fatty Liver Drug: Rimonabant Drug: Placebo (for Rimonabant) Phase 3

Detailed Description:
The total duration per patient will be approximately 28 months including a 24-month double-blind treatment period.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
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)
Study Start Date : January 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rimonabant
Rimonabant 20 mg once daily.
 Drug: Rimonabant
Tablet, oral administration
Other Names:
  • SR141716
  • Acomplia
Placebo Comparator: Placebo
Placebo (for Rimonabant) once daily.
 Drug: Placebo (for Rimonabant)
Tablet, oral administration


Outcome Measures
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Primary Outcome Measures :
  1. Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS) [ Time Frame: Baseline to 24 months ]

Secondary Outcome Measures :
  1. Change from baseline in hepatic fibrosis score [ Time Frame: Baseline to 24 months ]
  2. Change from baseline in serum hyaluronate (HA) [ Time Frame: Baseline to 24 months ]
  3. Change from baseline in hepatic transaminases (AST/ALT) [ Time Frame: Baseline to 24 months ]

Eligibility Criteria
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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576667


  Show 24 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00576667     History of Changes
Other Study ID Numbers: EFC10143
2007-003013-14 ( EudraCT Number )
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: April 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