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

Visão geral

• Género

  ALL

• Idade

  18 Anos ou mais

• Fase

  Não aplicável

• Tipo de Estudo

  INTERVENTIONAL

• Localização

  Sanofi-Aventis Administrative Office (Porto Salvo)
  

• Clinicaltrial.gov

  https://classic.clinicaltrials.gov/ct2/show/NCT00577148

Sumário

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.

Condições

Fatty Liver

Elegibilidade

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.

Detalhes

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