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An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients With Type 2 Diabetes

This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00577148
First received: December 18, 2007
Last updated: June 12, 2009
Last verified: June 2009
History of Changes
  Purpose

The purpose of this study is to assess the effect of rimonabant treatment on the histological features of NASH in patients with Type 2 diabetes.


Condition Intervention Phase
Fatty Liver
 Drug: rimonabant (SR141716)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Type 2 Diabetic Patients With Nonalcoholic Steatohepatitis (NASH).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in histologic features of NASH from baseline to end of treatment liver biopsy [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Liver fibrosis, AST/ALT, serum hyaluronate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: February 2008
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rimonabant (SR141716)
20 mg daily
Placebo Comparator: 2 Drug: Placebo
daily administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Type 2 diabetes mellitus and a diagnosis of NASH

Exclusion Criteria:

  • Excessive alcohol use
  • Presence of Type 1 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577148

  Hide Study Locations
Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Australia, New South Wales
Sanofi-Aventis Administrative Office
Cove, New South Wales, Australia
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
China
Sanofi-Aventis Administrative Office
Shangai, China
Colombia
Sanofi-Aventis Administrative Office
Santafe de Bogota, Colombia
Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Philippines
Sanofi-Aventis Administrative Office
Makati City, Philippines
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Puerto Rico
Sanofi-Aventis Administrative Office
Puerto Rico, Puerto Rico
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00577148     History of Changes
Other Study ID Numbers: EFC10144, EudraCT 2007-003013-14
Study First Received: December 18, 2007
Last Updated: June 12, 2009
Health Authority: Mexico: Ministry of Health

Keywords provided by Sanofi:
NASH
chronic liver disease

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013