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 )

First Received: December 18, 2007 Last Updated: March 13, 2009 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00577148

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 III

MedlinePlus related topics: Diabetes

Drug Information available for: SR 141716A Rimonabant

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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).

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	720
Study Start Date:	December 2007
Study Completion Date:	February 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: rimonabant (SR141716) 20 mg daily
2: Placebo Comparator	Drug: Placebo daily administration

Eligibility

Criteria

Inclusion Criteria:

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

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD )
Study ID Numbers:	EFC10144, EudraCT 2007-003013-14
Study First Received:	December 18, 2007
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00577148 History of Changes
Health Authority:	Mexico: Ministry of Health

Keywords provided by Sanofi-Aventis:

NASH
chronic liver disease

Study placed in the following topic categories:

Liver Diseases
Non-alcoholic Steatohepatitis (NASH)
Digestive System Diseases

Diabetes Mellitus, Type 2
Diabetes Mellitus
Fatty Liver

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Fatty Liver

ClinicalTrials.gov processed this record on May 07, 2009