An Efficacy and Safety Study of Rimonabant for Treatment... | NCT00577148

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

NCT00577148

Sponsor

Sanofi

Status

Terminated

Last Update Posted

May 18, 2016Estimated

Enrollment

89Actual

Phase

Phase 3

Conditions

Fatty Liver

Interventions

Rimonabant
Placebo (for Rimonabant)

Countries

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

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2007-003013-14	EudraCT Number

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company decision taken in light of demands by certain national health authorities

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Dec 18, 2007

First Submission Date that Met QC Criteria

Dec 18, 2007

First Posted Date

Dec 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Apr 18, 2016

Certification/Extension First Submitted that Passed QC Review

Apr 18, 2016

Certification/Extension First Posted Date

May 18, 2016Estimated

Last Update Submitted Date

Apr 18, 2016

Last Update Posted Date

May 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rimonabant	Experimental	Rimonabant 20 mg once daily.	Drug: Rimonabant
Placebo	Placebo Comparator	Placebo (for Rimonabant) once daily.	Drug: Placebo (for Rimonabant)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rimonabant	Drug	Tablet, oral administration	Rimonabant	SR141716

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS)		Baseline to 18 months

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in hepatic fibrosis score		Baseline to 18 months
Change from baseline in serum hyaluronate and hepatic transaminases (AST/ALT)		Baseline to 18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bridgewater	New Jersey	08807	United States
Sanofi-Aventis Administrative Office

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D010880	Piperidines