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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00577148




Registration number
NCT00577148
Ethics application status
Date submitted
18/12/2007
Date registered
19/12/2007
Date last updated
18/05/2016

Titles & IDs
Public title
An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients With Type 2 Diabetes
Scientific 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).
Secondary ID [1] 0 0
2007-003013-14
Secondary ID [2] 0 0
EFC10144
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatty Liver 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rimonabant
Treatment: Drugs - Placebo (for Rimonabant)

Experimental: Rimonabant - Rimonabant 20 mg once daily.

Placebo Comparator: Placebo - Placebo (for Rimonabant) once daily.


Treatment: Drugs: Rimonabant
Tablet, oral administration

Treatment: Drugs: Placebo (for Rimonabant)
Tablet, oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS)
Timepoint [1] 0 0
Baseline to 18 months
Secondary outcome [1] 0 0
Change from baseline in hepatic fibrosis score
Timepoint [1] 0 0
Baseline to 18 months
Secondary outcome [2] 0 0
Change from baseline in serum hyaluronate and hepatic transaminases (AST/ALT)
Timepoint [2] 0 0
Baseline to 18 months

Eligibility
Key inclusion criteria
- Patients with Type 2 diabetes mellitus and a diagnosis of NASH
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Cove
Recruitment postcode(s) [1] 0 0
- Cove
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Belgium
State/province [3] 0 0
Diegem
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
Chile
State/province [5] 0 0
Santiago
Country [6] 0 0
China
State/province [6] 0 0
Shangai
Country [7] 0 0
Colombia
State/province [7] 0 0
Santafe de Bogota
Country [8] 0 0
Croatia
State/province [8] 0 0
Zagreb
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Hungary
State/province [11] 0 0
Budapest
Country [12] 0 0
Italy
State/province [12] 0 0
Milan
Country [13] 0 0
Malaysia
State/province [13] 0 0
Kuala Lumpur
Country [14] 0 0
Mexico
State/province [14] 0 0
Mexico
Country [15] 0 0
Philippines
State/province [15] 0 0
Makati City
Country [16] 0 0
Poland
State/province [16] 0 0
Warszawa
Country [17] 0 0
Portugal
State/province [17] 0 0
Porto Salvo
Country [18] 0 0
Puerto Rico
State/province [18] 0 0
Puerto Rico
Country [19] 0 0
Romania
State/province [19] 0 0
Bucuresti
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Switzerland
State/province [21] 0 0
Geneva
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipei
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the effect of rimonabant treatment on the histological
features of Nonalcoholic Steatohepatitis (NASH) in patients with Type 2 diabetes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00577148
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00577148