NCT00699036Unknown2 期
Rosiglitazone Versus Rosiglitazone and Metformin (Avandamet) Versus Combination Rosiglitazone and Losartan in the Treatment of Nonalcoholic Steatohepatitis (NASH). A Prospective, Open-Label, Randomized Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- liver biopsy histologic improvement
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?
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
- None
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 between 18-70 years old
- •Negative urine pregnancy test in females
- •History of elevated liver associated enzymes (ALT > 40)
- •Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH
排除标准
- •ALT greater than three times normal
- •NYHA class 3 or 4 heart failure
- •Any congestive heart failure patient on insulin
- •Patients on one of the 3 study drugs within the past 3 months prior to enrollment
- •Alcohol consumption >20 gm/day in a female and > 30 gm/day in a male
- •Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis
- •Serum creatinine on initial screening of greater than 1.4
- •Known hypersensitivity to rosiglitazone, metformin, or losartan
- •Known history of diabetic ketoacidosis
- •Female that is breastfeeding
- •Insulin dependent diabetic
研究组 & 干预措施
3
Experimental
avandia plus losartan
干预措施: avandia (Drug)
3
Experimental
avandia plus losartan
干预措施: losartan (Drug)
1
Experimental
avandia
干预措施: avandia (Drug)
2
Experimental
avandia plus metformin
干预措施: avandia (Drug)
2
Experimental
avandia plus metformin
干预措施: metformin (Drug)
结局指标
主要结局
liver biopsy histologic improvement
时间窗: end of study
次要结局
- serum transaminases(throughout study (ongoing))
研究者
研究点 (1)
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