NCT00577148|TerminatedPhase 3DMC

Study Stopped

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

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

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).

Sanofi ClinicalTrials.gov

Compare

2 other identifiers

EFC101442007-003013-14

Study Type

interventional

Target

Locations

24 countries

Sites

Timeline

RegisteredDec 2007

StartedFeb 2008

CompletionFeb 2009

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 Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Feb 2008

Shorter than P25 for phase_3

Geographic Reach

24 countries

24 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

December 18, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed

1 month until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed

Last Updated

May 18, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

December 18, 2007

Last Update Submit

April 18, 2016

Conditions

Fatty Liver

Keywords

NASHchronic liver disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

Study Arms (2)

Rimonabant

EXPERIMENTAL

Rimonabant 20 mg once daily.

Drug: Rimonabant

Placebo

PLACEBO COMPARATOR

Placebo (for Rimonabant) once daily.

Drug: Placebo (for Rimonabant)

Interventions

RimonabantDRUG

Tablet, oral administration

Also known as: SR141716, Acomplia

Rimonabant

Placebo (for Rimonabant)DRUG

Tablet, oral administration

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with Type 2 diabetes mellitus and a diagnosis of NASH

You may not qualify if:

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.

Contact the study team to confirm eligibility.