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:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00576667
First received: December 18, 2007
Last updated: June 12, 2009
Last verified: June 2009

December 18, 2007
June 12, 2009
January 2008
November 2008   (final data collection date for primary outcome measure)
Change in histologic features of NASH from baseline to end of treatment liver biopsy [ Time Frame: 24 or more months ] [ Designated as safety issue: No ]
Change in histologic features of NASH from baseline to end of treatment liver biopsy [ Time Frame: 24 or more months ]
Complete list of historical versions of study NCT00576667 on ClinicalTrials.gov Archive Site
Liver fibrosis, AST/ALT, serum hyaluronate [ Time Frame: 24 or more months ] [ Designated as safety issue: No ]
Liver fibrosis, AST/ALT, serum hyaluronate [ Time Frame: 24 or more months ]
Not Provided
Not Provided
 
An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes
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)

The purpose of this study is to assess the effect of rimonabant treatment on the histological features of NASH.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fatty Liver
  • Drug: rimonabant (SR141716)
    20 mg daily
  • Drug: Placebo
    daily administration
  • Experimental: 1
    Intervention: Drug: rimonabant (SR141716)
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
165
February 2009
November 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Chile,   China,   Colombia,   Croatia,   France,   Germany,   Hungary,   Italy,   Malaysia,   Mexico,   Philippines,   Poland,   Portugal,   Puerto Rico,   Romania,   Spain,   Switzerland,   Taiwan,   United Kingdom
 
NCT00576667
EFC10143, EudraCT 2007-003013-14
Yes
ICD, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP