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).

TerminadoFase 3ClinicalTrials.gov

ID: NCT00577148Tipo: INTERVENTIONALInicio: 1 de feb de 2008Fin estimado: 1 de feb de 2009

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients with Type 2 diabetes mellitus and a diagnosis of NASH

Criterios de exclusión

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.

Intervenciones

drug

Rimonabant

Tablet, oral administration

drug

Placebo (for Rimonabant)

Tablet, oral administration

Ubicaciones

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Patrocinadores

PrincipalSanofi

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