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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Stopped early
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00577148