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

NCT ID: NCT00577148

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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The total duration per patient will be approximately 22 months including a 18-month double-blind treatment period.

Conditions

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Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rimonabant

Rimonabant 20 mg once daily.

Group Type EXPERIMENTAL

Rimonabant

Intervention Type DRUG

Tablet, oral administration

Placebo

Placebo (for Rimonabant) once daily.

Group Type PLACEBO_COMPARATOR

Placebo (for Rimonabant)

Intervention Type DRUG

Tablet, oral administration

Interventions

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Rimonabant

Tablet, oral administration

Intervention Type DRUG

Placebo (for Rimonabant)

Tablet, oral administration

Intervention Type DRUG

Other Intervention Names

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SR141716 Acomplia

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis Administrative Office

Buenos Aires, , Argentina

Site Status

Sanofi-Aventis Administrative Office

Cove, New South Wales, Australia

Site Status

Sanofi-Aventis Administrative Office

Diegem, , Belgium

Site Status

Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Site Status

Sanofi-Aventis Administrative Office

Santiago, , Chile

Site Status

Sanofi-Aventis Administrative Office

Shanghai, , China

Site Status

Sanofi-Aventis Administrative Office

Bogotá, , Colombia

Site Status

Sanofi-Aventis Administrative Office

Zagreb, , Croatia

Site Status

Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Sanofi-Aventis Administrative Office

Berlin, , Germany

Site Status

Sanofi-Aventis Administrative Office

Budapest, , Hungary

Site Status

Sanofi-Aventis Administrative Office

Milan, , Italy

Site Status

Sanofi-Aventis Administrative Office

Kuala Lumpur, , Malaysia

Site Status

Sanofi-Aventis Administrative Office

México, , Mexico

Site Status

Sanofi-Aventis Administrative Office

Makati City, , Philippines

Site Status

Sanofi-Aventis Administrative Office

Warsaw, , Poland

Site Status

Sanofi-Aventis Administrative Office

Porto Salvo, , Portugal

Site Status

Sanofi-Aventis Administrative Office

San Juan, , Puerto Rico

Site Status

Sanofi-Aventis Administrative Office

Bucharest, , Romania

Site Status

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Site Status

Sanofi-Aventis Administrative Office

Geneva, , Switzerland

Site Status

Sanofi-Aventis Administrative Office

Taipei, , Taiwan

Site Status

Sanofi-Aventis Administrative Office

Guildford, Surrey, United Kingdom

Site Status

Countries

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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

Other Identifiers

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2007-003013-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC10144

Identifier Type: -

Identifier Source: org_study_id

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