NCT00576667终止3 期
A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Non-diabetic Patients With Nonalcoholic Steatohepatitis (NASH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS)
研究概览
简要总结
The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).
详细描述
The total duration per patient will be approximately 28 months including a 24-month double-blind treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of NASH
排除标准
- •Excessive alcohol use
- •Presence of 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.
研究组 & 干预措施
Rimonabant
Experimental
Rimonabant 20 mg once daily.
干预措施: Rimonabant (Drug)
Placebo
Placebo Comparator
Placebo (for Rimonabant) once daily.
干预措施: Placebo (for Rimonabant) (Drug)
结局指标
主要结局
Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS)
时间窗: Baseline to 24 months
次要结局
- Change from baseline in serum hyaluronate (HA)(Baseline to 24 months)
- Change from baseline in hepatic transaminases (AST/ALT)(Baseline to 24 months)
- Change from baseline in hepatic fibrosis score(Baseline to 24 months)
研究者
研究点 (1)
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